FIELD CORRECTIVE ACTION LISTING FOR OCTOBER 2023
The list below contains Medical Device’s Field Corrective Action for the month of October 2023. This list provides field corrective action reporting information to MDA by establishment in accordance to requirement stipulated in Section 41, Act 737 and Regulation 6 of Medical Device (Duties and Obligations of Establishment) Regulations 2019.
Field Corrective Action (FCA) is part of a post-marketing risk assessment measure to ensure the continued safe use of medical devices in the Malaysia market. It is a corrective or preventive action in relation to a medical device which may include –
(a) The return of the medical device to the establishment;
(b) Modification of the medical device;
(c) Exchange of the medical device;
(d) Destruction of medical device; or
(e) Specific advice on the use of the medical device.
If you have experienced any safety and performance issue with one of the medical devices listed for FCA action, please seek advice from your medical device authorised representative as soon as possible.
|
No |
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
1 |
8 November 2023 |
Urgent Field Safety Notice on Software Upgrade of ID NOW Instrument |
ID NOW™ INSTRUMENT |
MDA/FCA/P0564-22155588-2023 |
IVDC4177623-150835 |
When using the current version of ID NOW software, version 7.0, users have the ability to run the ID NOW COVID-19 2.0 and ID NOW Influenza A&B 2 test sequentially, from one patient sample. Some customers have reported an increase in Influenza B false positive test results when using the device in this manner. |
WINNIE HII LIN LIN SENIOR REGULATORY AFFAIRS SPECIALIST ABBOTT DIAGNOSTICS HEALTH SDN BHD |
|
2 |
8 November 2023 |
TRANSFER SET |
MDA/FCA/PX0587-75794058-2023 |
GA84078400417 |
Complaints received on "Transfer Set" leaking which indicates tubing failure in tubing |
NOOR IBTISYAM BINTI MOHAMAD ADNAN REGULATORY AFFAIRS EXECUTIVE ADVENTA HEALTHCARE SDN. BHD. |
|
|
3 |
30 October 2023 |
FSCA-2023-08-14 (1) // Infusomat® Space - Upstream Occlusion Sensor |
INFUSION PUMP |
MDA/FCA/PX0540-92348718-2023 |
GC92724141717 |
In the course of Post Market Surveillance activities, we identified a sporadic occurrence of potentially false downand upstream pressure alarms which are caused by the upstream occlusion pressure sensor of the Infusomat® Space Infusion Pump. |
QUEK LANG FAH HEAD OF REGULATORY AFFAIRS B. BRAUN MEDICAL INDUSTRIES SDN. BHD. |
|
4 |
6 November 2023 |
ENTERPRISE 9000X |
MDA/FCA/P0550-24471944-2023 |
GMD85545422818A |
Malfunction leading to the unintended movement of bed wheels |
CHONG WAI MUN GENERAL MANAGER BEST CONTACT (M) SDN BHD |
|
|
5 |
4 October 2023 |
MA 2023 0006 DRX Revolution Mobile X-ray System CPI Generator Issue |
DRX-REVOLUTION MOBILE X-RAY SYSTEM |
MDA/FCA/P0530-99906041-2023 |
GC52334161417 |
There is a potential for unexpected failure of the electrical components within the Communication & Power Industries, Inc (CPI) generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self-contained thermal overload within the generator. |
WNG AH LIN BUSINESS ADMINISTRATOR CARESTREAM HEALTH (M) SDN BHD |
|
6 |
6 October 2023 |
Revision on stability sections in Product Insert- Lyphochek Hemoglobin A2 Control |
HEMOGLOBIN CONTROL |
MDA/FCA/P0544-63864384-2023 |
IVDB3773471217 |
Bio-Rad, the manufacturer has observed that Hemoglobin F may not meet the reconstituted refrigerated (2 to 8°C) storage stability claims as printed in the package insert. The stability claims for Hemoglobin F have been revised as indicated by the highlighted text and bold font in the FSN. |
ADELINE NG POOI KUAN GROUP CORPORATE COMPLIANCE SENIOR MANAGER CHEMOPHARM SDN BHD |
|
7 |
22 November 2023 |
Possible shutdown of Dräger anesthesia workstation Atlan due to possible backup battery failures |
ATLAN |
MDA/FCA/P0597-86266273-2023 |
GC7299919-37202 |
Within our market surveillance activities regarding our anesthesia workstation Atlan we became aware of a few cases in which the internal backup battery failed spontaneously while the Atlan is being operated without mains supply. This resulted in an unexpected shutdown of the device while it was running on batteries. |
BEATRICE MAH WAN XIN QUALITY AND REGULATORY AFFAIR SPECIALIST DRAEGER MALAYSIA SDN BHD |
|
8 |
17 October 2023 |
Potential for Loose Universal Surgical Manipulators (USM) on da Vinci X and Xi Systems |
DA VINCI XI SURGICAL SYSTEM, ENDOSCOPIC INSTRUMENT CONTROL SYSTEM, MODEL IS4000 |
MDA/FCA/P0553-57377033-2023 |
GC3810021-64842 |
A population of the da Vinci X and Xi system instrument arms (USMs) have Instrument Carriages that may separate from the Insertion Axis Linear Rail during shipping, handling, or repositioning of the arms when the system is powered down. The Instrument Carriage would remain attached to the drive motor which prevents free-fall motion or complete detachment from the USM |
RYAN YEO CHOON HWEE REGULATORY AFFAIRS MANAGER, SOUTH EAST ASIA DTG MEDICAL SDN BHD |
|
9 |
26 October 2023 |
TRUWAVE DISPOSABLE PRESSURE TRANSDUCER AND VAMP SYSTEM |
MDA/FCA/P0562-24787716-2023 |
GB838093516 |
As per product evaluation, the Flow restrictor was located further into the housing and blocked the flow path below the poppet. Therefore, Acumen IQ units were not able to be primed due to occlusion within flush device. |
WONG WAI YI REGULATORY AFFAIRS SPECIALIST EDWARDS LIFESCIENCES (MALAYSIA) SDN BHD |
|
|
10 |
24 October 2023 |
HEMOSPHERE ADVANCED MONITORING PLATFORM |
MDA/FCA/P0563-39428819-2023 |
GC766371236819 |
|||
|
11 |
23 October 2023 |
PD TUBING SYSTEM |
MDA/FCA/P0531-92558309-2023 |
GB5396719-32241 |
Based on current literature, it has been recognized that an increased exposure to povidone-iodine, a potent antiseptic present in the stay safe Disinfection Cap used to close the PD catheter extension could lead to iodine-induced hypothyroidism and associated clinical sequelae. |
SHARON DING WENSZE REGULATORY AFFAIRS MANAGER FRESENIUS MEDICAL CARE MALAYSIA SDN BHD |
|
|
12 |
10 October 2023 |
OEC ELITE |
MDA/FCA/P0547-33670176-2023 |
GC35179812618 |
GE HealthCare has become aware that the 9-inch Image Intensifier for OEC Flexiview 8800, OEC 9800, OEC 9900 and OEC Elite systems can become detached if the systems encounter a large impact force when moved. No instances of this issue have occurred in clinical use. GE HealthCare became aware of one instance of image intensifier detachment during shipment. |
LIM SOCK SIANG DIRECTOR GE HEALTHCARE SDN. BHD |
|
|
13 |
10 October 2023 |
OEC ELITE |
MDA/FCA/P0548-40580869-2023 |
GC6766523-114390 |
|||
|
14 |
12 October 2023 |
Field Corrective Action for ExtraFit Latex Examination Gloves, Powdered with Powder Issue |
LATEX EXAMINATION GLOVES, POWDERED |
MDA/FCA/PX0520-35151668-2023 |
GA3428235816 |
Meditech Gloves Sdn. Bhd. has initiated a field corrective action for the ExtraFit Latex Examination Gloves, Powdered product due to customer complaints received, indicating issues with uneven powder and clumps that have transferred to both equipment and patients who have come into contact with the gloves despite having powder content well within the specification limit. |
HASNAH BINTI ABDUL HAMID QUALITY ASSURANCE MANAGER MEDITECH GLOVES SDN BHD |
|
15 |
2 October 2023 |
STEALTHSTATION S8 CRANIAL SYSTEM |
MDA/FCA/P0535-60608026-2023 |
GC7686023-140750 |
Medtronic has identified a software anomaly in StealthStation™ S8 Software App versions 2.0 and 2.0.1 that can occur within a Cranial (including DBS and Stereotaxy) or ENT procedure type, while merging exams with StealthMerge™ or StealthMerge™ ENT software, |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
|
16 |
STEALTHSTATION S8 SPINAL SYSTEM |
MDA/FCA/P0536-34928297-2023 |
GC6531123-143275 |
||||
|
17 |
STEALTHSTATION S8 ENT SYSTEM |
MDA/FCA/P0537-60192016-2023 |
GC771281137418 |
||||
|
18 |
STEALTHSTATION FLEXENT SYSTEM |
MDA/FCA/P0538-55405759-2023 |
GC6421521-58428 |
||||
|
19 |
10 October 2023 |
FA1370 McGRATH MAC Video Laryngoscopes Misappropriated Devices |
McGRATH MAC Video Laryngoscope |
MDA/FCA/P0542-68105454-2023 |
GA7934120-46549 |
A number of McGrath MAC Video Laryngoscopes [SKU 301-000-000] dispositioned as scrap at the contract manufacturer (CM) Plexus has been found for sale on social media platforms, Facebook Market Place and Mercado Libre. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
20 |
5 October 2023 |
NIM-NEURO 3.0 SYSTEM AND ACCESSORIES |
MDA/FCA/P0543-40274208-2023 |
GB45802845818 |
Medtronic has received complaint reports from customers experiencing issues with the NIM™ Standard Reinforced EMG Endotracheal Tube & NIM CONTACT™ Reinforced EMG Endotracheal Tube during use. It was reported that the cuff of the endotracheal EMG tube was over-inflated, causing it to herniate over the end of the tube leading to loss of ventilation due to airway blockage. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
|
21 |
13 October 2023 |
MINIMED MIO INFUSION SET |
MDA/FCA/P0551-21039693-2023 |
GC8179022-89707 |
Every home use device marketed by Medtronic in Malaysia must contain the Instructions for Use (IFU) with correct information in the Malay language. Per the current process at Medtronic Malaysia, when material is received, the packaging box is reworked to include the Malay language IFU |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
|
22 |
20 October 2023 |
MINIMED 780G SYSTEM AND ACCESSORIES |
MDA/FCA/P0555-27176012-2023 |
GC4190021-62126 |
A reliability analysis was conducted and determined that all consignees with pumps aged older than 1 year should receive backup battery caps. The reliability report noted that the battery cap metal contact issue is a wear out phenomenon and therefore the risk of the pump losing power increases the longer the pump is in use. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
|
23 |
MINIMED 700 INSULIN PUMP AND KIT |
MDA/FCA/P0556-30139830-2023 |
GC8922821-64034 |
||||
|
24 |
MINIMED 640G SYSTEM AND ACCESSORIES |
MDA/FCA/P0557-96661538-2023 |
GC8430922-106837 |
||||
|
25 |
27 October 2023 |
HEARTWARE VENTRICULAR ASSIST SYSTEM (HVAD) |
MDA/FCA/P0572-51089984-2023 |
GD74345985518 |
The HVAD System has features and components, such as the internal battery in the controller, which are expected to eventually wear out or otherwise reach the end of their useful life, as is inherent in any such physical system. To help inform on how long the controller could be expected to perform before reaching end of useful life, the existing Instructions for Use and Patient Manual contain training and guidance (see Table 5) on length of useful life and management of the controller. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
|
26 |
16 October 2023 |
MINIMED MIO INFUSION SET |
MDA/FCA/PX0552-67361328-2023 |
GC8179022-89707 |
Every home use device marketed by Medtronic in Malaysia must contain the Instructions for Use (IFU) with correct information in the Malay language. Per the current process at Medtronic Malaysia, when material is received, the packaging box is reworked to include the Malay language IFU. |
CHOW SOON YEE REGULATORY AFFAIRS LEAD MEDTRONIC MALAYSIA SDN BHD |
|
|
27 |
30 October 2023 |
Potential for uncontrolled extension of XVI / iViewGT™ detector arms |
ELEKTA MEDICAL LINEAR ACCELERATOR (EMLA) |
MDA/FCA/P0574-45275425-2023 |
GC8284822-112386 |
Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT™ / XVI detector arms. When the detector arm is fully deployed there is no risk of uncontrolled extension. |
BHARAT KUMAR A/L VRAJLAL PREMCHAND DIRECTOR NYPRAX BUSINESS SOLUTIONS |
|
28 |
2 October 2023 |
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE SYSTEM |
MDA/FCA/P0515-24057168-2023 |
GB41963114717 |
Olympus found that certain lots of the CV-190 do not start up properly and as a result, the image from the endoscope is not displayed when the operations listed below are performed because parts that deviated from the specification were assembled into the power supply unit. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
29 |
4 October 2023 |
HIGH FLOW INSUFFLATION UNIT |
MDA/FCA/P0528-92249188-2023 |
GB929511113418 |
The overpressure condition was caused by the following two Hazardous Situations. (1) Overpressure without device abnormality (UHI-4 normal state without abnormality) (2) Over pressurization due to uncontrolled cavity pressure caused by equipment failure. (UHI-4 failure state) |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
30 |
2 October 2023 |
Revised Instructions of Updated Drying Procedure for the GIF-1TH190. |
EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE SYSTEM |
MDA/FCA/P0534-71896576-2023 |
GB41963114717 |
This Field Safety Notice is based on the reprocessing validation for a Catch-Up 510(k) application to be submitted to the FDA on this model. The reprocessing validation results for EOG sterilization of the GIF-1TH190 did not meet the criteria of “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff”, issued March 17, 2015 (2015 reprocessing guidance). |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
31 |
17 October 2023 |
EVIS X1 VIDEO SYSTEM CENTER |
MDA/FCA/P0549-18524426-2023 |
GB2460720-48587 |
This Field Safety Notice based on the complaint received outside Malaysia that the water delivery tube hit the touch panel and the air delivery button was unintentionally turned on during the procedure. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
|
32 |
26 October 2023 |
Reminding the WARNINGS within Olympus bronchoscope’s Operation Manual. |
EVIS LUCERA ELITE BRONCHOVIDEOSCOPE SYSTEM |
MDA/FCA/P0567-89902217-2023 |
GB66358142517 |
This Field Safety Notice based on the complaint received outside Malaysia that the water delivery tube hit the touch panel and the air delivery button was unintentionally turned on during the procedure. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
33 |
EVIS EXERA III BRONCHOVIDEOSCOPE SYSTEM |
MDA/FCA/P0569-47659304-2023 |
GB58878308917 |
||||
|
34 |
OPTERA VIDEO SYSTEM |
MDA/FCA/P0571-87040392-2023 |
GB15542818418 |
||||
|
35 |
2 November 2023 |
Flexible Endoscopes Serviced at Olympus Repair Centre May Have Residual Channel Moisture. |
EVIS EXERA III BRONCHOVIDEOSCOPE SYSTEM |
MDA/FCA/P0579-93618134-2023 |
GB58878308917 |
This Field Safety Notice is based on the 3 complaints received outside Malaysia about water dripping off from the distal end of demo/loaner endoscopes. According to the Inspection Manual issued by OMSC (Olympus Medical Systems Co., Ltd), repair production control had instructed the worldwide repair centers to drain water from the entire channel system after inspection and check if there is no water residue in the channel. |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD. |
|
36 |
7 November 2023 |
ENDOEYE HD II |
MDA/FCA/P0584-16111136-2023 |
GB45912709718 |
This Field Safety Notice is initiated based on an increased complaint rate outside Malaysia that is related to “pink or green images” of the Video Laparoscopes ENDOEYE HD II (WA50040A and WA50042A). |
YEOH SEO CHING, SHELLY MANAGER, QUALITY ASSURANCE & REGULATORY AFFAIRS OLYMPUS (MALAYSIA) SDN. BHD |
|
|
37 |
5 October 2023 |
|
XPER FLEX CARDIO PHYSIOMONITORING SYSTEM |
MDA/FCA/P0541-81082167-2023 |
GC95469295617 |
Following exposure to defibrillation voltage, the system returns to normal operating mode within 5 seconds. However, if the Xper Flex Cardio Devicehas been exposed to greater than the specified energy related to the defibrillator and/or ESU use, it might fail to return to normal operating mode within 5 seconds and it may require a restart in order to continue ECG monitoring. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
38 |
5 October 2023 |
AZURION 5 |
MDA/FCA/P0545-22716940-2023 |
GC10785320-48186 |
Philips has identified a potential safety issue where the Philips Azurion system may unexpectedly lose X-ray functionality. Due to a software issue, a mechanism that is present in the system to manage the number and size of Log Trace Files does not function properly. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
39 |
23 October 2023 |
HeartStart Intrepid Monitor/Defibrillator (867172) Service Manual Electrical Safety Test Issue
|
HEARTSTART INTREPID |
MDA/FCA/P0561-32186601-2023 |
GC2897720-42451 |
The current HeartStart Intrepid Service Manual does not detail IEC Class I electrical safety test verification methods. The lack of this testing does not introduce a failure, but it may prevent a failure from being detected. This could occur when an IEC Class I device is tested as a Class II device after a servicing event. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
40 |
26 October 2023 |
FSN 2023-PD-MR-014 Achieva 1.5T,
|
ACHIEVA SERIES |
MDA/FCA/P0566-89461896-2023 |
GB44884842218 |
hilips has identified an issue where a specific component failure in the Gradient Coil of the affected 1.5T MR Systems listed in this letter may act as a heat source with a potential to produce smoke and/or fire. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
41 |
16 November 2023 |
ALLURA XPER FD SERIES |
MDA/FCA/P0588-48405519-2023 |
GC59365128817 |
Philips has identified a potential safety issue with the Philips Allura and Azurion Product Families having monoplane fixed ceiling mounted systems. The ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur. |
ZAM ZARINA BINTI MAT AIL Q&R MANAGER PHILIPS MALAYSIA SDN BERHAD |
|
|
42 |
AZURION 7 |
MDA/FCA/P0589-90484518-2023 |
GC82521235717 |
||||
|
43 |
4 October 2023 |
ACROBAT-I VACUUM STABILIZER SYSTEM |
MDA/FCA/P0522-28049082-2023 |
GB3805023-133245 |
Maquet/Getinge is initiating a voluntary Medical Device Field Safety Notice-Removal for the ACCESSRAIL Platform Standard Blade and Deep Blade due to the blade not securely latching onto the Activator Drive. |
HEW SOOK PEI ADMIN MANAGER RBD HEALTHCARE SDN BHD |
|
|
44 |
31 October 2023 |
Unintended Movement from travel unit at MEERA operating tables |
MEERA, MEERA ST |
MDA/FCA/P0575-35899350-2023 |
GA2599721-82114 |
Under certain conditions, we have identified that an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive and triggers an unintended driving (autodrive) of max. 7 sec. |
HEW SOOK PEI ADMIN MANAGER RBD HEALTHCARE SDN BHD |
|
45 |
20 November 2023 |
ResMed Masks with Magnets and Potential Magnetic Interference with Certain Medical Devices |
AIRFIT N20 |
MDA/FCA/P0591-73546052-2023 |
GB95390436717 |
The reported injuries included pacemaker failure leading to pacemaker replacement, a need for shunt adjustment, resetting of automatic implantable cardioverter defibrillator, arrhythmia, cognitive changes, headaches, change in heartrate (tachycardia, bradycardia), convulsions (seizures), and irregular blood pressure.” |
NAZATUL ASHIKIN BINTI REZUAN SENIOR QUALITY ASSURANCE ENGINEER RESMED MALAYSIA OPERATIONS SDN. BHD. |
|
46 |
11 October 2023 |
Surgical Microscopes: M530 OHX, PROvido, Proveo 8 FSCA Identifier: CAPA-LIS-MD-22-001 Replacement of Power Supply Unit
|
PROVIDO Surgical Microscope |
MDA/FCA/P0546-90235430-2023 |
GA6844423-140492 |
Leica Microsystems has become aware of process weaknesses of the sub-supplier producing the affected Power Supply Unit. These process weaknesses have caused that the Power Supply can become overheated due to internal component overstressing. |
NOOR FAIZAH BINTI KAMARUDIN REGULATORY AFFAIRS EXECUTIVE SCHMIDT BIOMEDTECH SDN BHD |
|
47 |
21 November 2023 |
ABIAN NEONATAL / PEDIATRIC VENTILATORS |
MDA/FCA/P0594-37401721-2023 |
GC92488887018 |
The purpose of this communication is to inform you that a software upgrade (software version 5.2.1) and revised Instructions for Use associated with FSCA-21-002, as communicated in the original Field Safety Notice (FSN) FSCA-21-002_FSCA-21-003-FSN-1, are now available for the fabian HFO, fabian +nCPAP evolution, and fabian Therapy evolution ventilators. |
NOOR FAIZAH BINTI KAMARUDIN REGULATORY AFFAIRS EXECUTIVE SCHMIDT BIOMEDTECH SDN BHD |
|
|
48 |
5 October 2023 |
RAPIDPOINT 500 |
MDA/FCA/P0539-38330352-2023 |
IVDC6984796818 |
Siemens Healthcare Diagnostics Inc. has determined that two drugs, Perhexiline Maleate and Atomoxetine Hydrochloride, may interfere with Sodium results that are reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
|
49 |
26 October 2023 |
EPOC BLOOD ANALYSIS SYSTEM |
MDA/FCA/P0560-73047662-2023 |
IVDC7557621-75750 |
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under specific conditions when the (automatic) Delete Blood Tests feature is enabled. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
|
50 |
26 October 2023 |
ATELLICA® IM FREE PROSTATE‑SPECIFIC ANTIGEN (FPSA) |
MDA/FCA/P0570-60011856-2023 |
IVDC82776266818 |
Our records indicate that your facility may have received the product(s) listed in Table 1. Siemens Healthcare Diagnostics Inc. has confirmed the potential for invalid calibrations with the fPSA assay due to the “low calibrator deviation” parameter resulting outside of the defined specification range. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
|
51 |
31 October 2023 |
EPOC BLOOD ANALYSIS SYSTEM |
MDA/FCA/P0576-26085425-2023 |
IVDC7557621-75750 |
Siemens Healthcare Diagnostics Inc. has confirmed an occurrence of the epoc Host2 device freezing during analysis when the “Use this ID” button is pressed while the system is performing test result calculations. This issue only occurs when the epoc Host2 is used with the PPID feature during calculations. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
|
52 |
7 November 2023 |
006 FSCA POC 24-004 RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) - Potential for Low Na+ Values and Question Result Error flags 10_53.pdf |
RAPIDPOINT 500 |
MDA/FCA/P0583-84567939-2023 |
IVDC6984796818 |
Complaints were received regarding discrepant Na+ results (low Na+ Bias). The associated complaints are captured in the Parent investigation ticket 2023-00013922. The investigation of this issue focuses on the Na+ performance given that some of the alleged biases exceed the total allowable error of > +/- 4mM (1mM = 1mmol/L). |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
53 |
21 November 2023 |
DIMENSION® IRON FLEX® REAGENT CARTRIDGE |
MDA/FCA/P0596-98021662-2023 |
IVDB3764328117 |
Siemens Healthineers’ internal testing has determined that the IRON assay, for use on the Dimension Clinical Chemistry System, has lipemia interference claims in the Instructions For Use (IFU) that require updates as shown in Table 2. While Siemens has not received any customer complaints for this issue, grossly lipemic samples have the potential to falsely elevate iron results on the Dimension Clinical Chemistry System. |
LAM YEN LI HEAD OF QUALITY & TECHNOLOGY SIEMENS HEALTHCARE SDN. BHD. |
|
|
54 |
2 November 2023 |
GEM® PREMIER™ 3500 SYSTEM |
MDA/FCA/P0577-83510019-2023 |
IVDC7302023-115078 |
This notification is intended to advise you regarding a potential performance issue with the following specific GEM PAKs for the GEM Premier 3000/3500, 4000 with iQM/iQM2 (Intelligent Quality Management) |
CHAI AI LIN MANAGER STRAITS SCIENTIFIC (M) SDN BHD |
|
|
55 |
2 November 2023 |
GEM PREMIER 5000 BLOOD GAS SYSTEM |
MDA/FCA/P0578-38696993-2023 |
IVDC33500201118 |
|||
|
56 |
30 October 2023 |
ORTHO VISION ANALYZER SYSTEM |
MDA/FCA/P0573-38882849-2023 |
IVDD4853923-138156 |
During an internal review, QuidelOrtho identified that Test ID 10023 included calculated Rh (Anti-D or RhD) Interpretation Result when in fact, no Anti-D column was used for the test. |
MENG TSE LEEAU MANAGING DIRECTOR T T MEDICAL MANAGEMENT SDN BHD |