FIELD CORRECTIVE ACTION (FCA) LISTING FOR JULY 2022
The list below contains Medical Device’s Field Corrective Action for the month of July 2022. 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 –
- The return of the medical device to the establishment;
- Modification of the medical device;
- Exchange of the medical device;
- Destruction of medical device; or
- 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.
|
Date received |
Title of FCA |
Affected Medical Device |
MDA Reference Number |
MDA Registration Number |
Description |
Local Establishment Contact Detail |
|
1 July 2022 |
Da Vinci S/Si Large Clip Applier, Da Vinci X/Xi Large Clip Applier |
MDA/FCA/2022-P108 |
GC74543334017, GC3810021-64842 |
Intuitive has become aware of the potential for unexpected motion caused due to partial disengagement of the instrument from the system while using the da Vinci S/Si and X/Xi EndoWrist Clip Applier instruments. |
Ryan Yeo Regulatory Affairs Manager - Asia DTG MEDICAL SDN.BHD. |
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4 July 2022 |
SYSMEX AUTOMATED BLOOD COAGULATION ANALYZER CA-600 SERIES |
MDA/FCA/2022-P109 |
IVDC8240021-69698 |
Customer perceived a burning smell out of CA-600 series mainly combined with error messages like “Z-axis Down Error”, “Z-axis Home Position Error” and/or “Voltage Low Limit”. |
Dinesh Vijian Regulatory Affairs Specialist Sysmex (Malaysia) Sdn Bhd |
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1 July 2022 |
FCA Notification on mislabelling of the product registration number |
Alpha Ortho- K AC Toric |
MDA/FCA/2022-P110 |
GB3290919-35867 |
Mislabelling of the product registration |
Ms Nicole Kang Regulatory Affairs Officer Mandarin Opto-Medic Sdn Bhd |
|
11 July 2022 |
06917259001 Ventana HE 600 system |
MDA/FCA/2022-P111 |
IVDA2632457317 |
Roche has confirmed 2 complaints regarding fluid leaks within the middle stainer module of the VENTANA HE 600 that likely resulted in electrical shorts at the plate heater connections that then escalated into fires. No physical harm or injury was reported. |
Tiffany Soon Regulatory Affairs Executive Roche Diagnostics (M) Sdn. Bhd. |
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7 July 2022 |
FCA Notification on the uninstallation of 4566 111 Model 2868 software from Model 3120 ZOOM programmers. |
Zoom Latitude Programming System (Model 2868 Programmer Software Application) |
MDA/FCA/2022-P112 |
GD9406621-82064 |
When designing the Tachy Model 3868 software maintenance release (SMR) version 15 upgrade for the Model 3300 LATITUDE Programmer, a decision was made to forego the design and development work needed to ensure the Model 3120 ZOOM Programmer Tachy software was compatible with SMR 15 PGs (Pulse Generators). |
Nor Syawalia Mohd Nor Associate RA Specialist Boston Scientific (M) Sdn Bhd |
|
7 July 2022 |
AXIOM Sensis XP, Sensis / Sensis Lite or Sensis Vibe Combo |
MDA/FCA/2022-P113 |
Sensis, Sensis Lite - GC58192270417 Sensis Vibe Combo - GC26491801918 |
The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box. The provided hooks support the possibility of mounting the Signal Input Box on an accessory rail (e.g. at the patient table) or in some similar environment where rail mounting is possible. When the mounting position deviates from the default position there is a need to observe additional restrictions. |
NUR AYUNI BINTI ABAS QUALITY TECHNOLOGY EXECUTIVE SIEMENS HEALTHCARE SDN BHD |
|
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13 July 2022 |
ORTHO Vision Max™ Analyzer and ORTHO VisionTM Analyzer |
MDA/FCA/2022-P114 |
IVDD33166265118 |
Ortho Clinical Diagnostics has received complaints from users regarding their analyser’s inability to properly pierce the foil on the cassettes, which may lead to a punch error code, GRIP06 error code [“Card / Cassette could not be punched correctly”]. |
MELISA LEEAU Director T T Medical Management Sdn Bhd |
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13 July 2022 |
Sysmex Automated Coagulation Analyzer CN Series |
MDA/FCA/2022-P115 |
IVDC6362721-66356 |
Sysmex found that the liquid level may be erroneously detected with the measurement error during the probe descending to aspirate the reagent if a cleaning liquid adheres to the reagent probe tip. Re-testing is required for measuring samples with the measurement error |
Dinesh Vijian Regulatory Affairs Specialist Sysmex (Malaysia) Sdn Bhd |
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14 July 2022 |
Automatic QC Cartridge Kit |
MDA/FCA/2022-P116 |
IVDC6984796818 |
Siemens Healthcare Diagnostics Inc. has confirmed an issue with the pH AQC Level 2 results recovering out of range low with the AQC cartridge lots listed above in Table 1. The pH AQC Level 2 published range is 7.350 +/-0.02. |
NG WEIL SHERN QUALITY TECHNOLOGY EXECUTIVE SIEMENS HEALTHCARE SDN BHD |
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14 July 2022 |
Centricity High Acuity Anesthesia (CHA-A) and Centricity High Acuity Critical Care (CHA-CC) |
MDA/FCA/2022-P117 |
GMD29146275517A, GA2352020-44975 |
GE Healthcare has become aware of an issue where information from two different patients can be mixed up in Centricity High Acuity Anesthesia (CHA-A) and Centricity High Acuity Critical Care (CHA-CC) applications when the same value is entered in the Social Security Number (SSN) field for these patients. |
Sharon Lee Regulatory Affairs Assistant GE Healthcare Sdn Bhd |
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15 July 2022 |
cobas e 801 analytical unit (08454345001) cobas e 801 module (07682913001) cobas pro sample supply unit (08464502001) cobas Pro SSU (09205632001) cobas 8000 core unit (05641446001) |
MDA/FCA/2022-P118 |
IVDA10967919-27203 IVDA2140019-30094 IVDA4229621-76338 |
Roche was recently informed by the manufacturer Hitachi High-Tech Corporation (HHT) about an internally detected operational software issue affecting cobas pro/cobas 8000 e 801 analytical units. |
Tiffany Soon Regulatory Affairs Executive Roche Diagnostics (M) Sdn. Bhd. |
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18 July 2022 |
FCA Notification on Paint Chipping issues on the Volista Operating Theatre Light |
Volista Operating Theatre Light |
MDA/FCA/2022-P119 |
GA6871371816 |
Maquet SAS/Getinge is initiating a voluntary Medical Device Correction for the VOLISTA StandOp Surgical Lights due to the potential for paint chipping to occur on the component (reference ARD568801164) located on the fork of the Volista StandOp Cupolas. |
Huda Tajuddin Retgulatory Executive IDS Medical Systems (M) Sdn Bhd |
|
15 July 2022 |
EliA ANA Positive Control 250 |
MDA/FCA/2022-P120 |
IVDB43283287718 |
An issue with the product EliA ANA Positive Control 250 for the dsDNA parameter has been discovered. Complaints have been reported where customers have received results around or over the upper limit for EliA ANA Positive Control 250. During internal review high results for the EliA dsDNA parameter from Bulk lot 0078 (filling C9REF, C9REG, C9REH, C9REJ) was confirmed. |
Najah Suadah Zakaria Regulatory & QA Executive Biomarketing (M) Sdn Bhd |
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15 July 2022 |
HAMILTON C6 Ventilator |
MDA/FCA/2022-P121 |
GC25545945118 |
Analysis of customer complaints revealed a hardware issue related to the status indicator board which can become loose and may result in a loose contact to the mainboard and potentially oxidation of this contact due to ingress of water (e.g., disinfectants). |
DIANA RAZAK HEAD OF QUALITY ASSURANCE STAR MEDIK SDN BHD |
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22 July 2022 |
Centricity Universal Viewer, Universal Viewer |
MDA/FCA/2022-P122 |
GB88139558518, GB7553622-96944 |
Distance and Area measurements can display inaccurate measurement values that are overestimated (measurement size is larger than true size) when a study is launched in Global Stack viewport on Centricity Universal Viewer and Universal Viewer. |
Sharon Lee Regulatory Affairs Assistant GE Healthcare Sdn Bhd |
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25 July 2022 |
FCA Notification on ATCC 19606 (Acinetobacter baumannii ATCC® 19606), ATCC 13253 (Elizabethkingia menigoseptica ATCC® 13253) and blank (NF reagent) gave a positive reaction where it should have given a negative reaction within the NO3 well of the panel. |
Remel RapID™ NF Plus System |
MDA/FCA/2022-P123 |
IVDB22180261018 |
A technical investigation has determined ATCC 19606 (Acinetobacter baumannii ATCC® 19606), ATCC 13253 (Elizabethkingia menigoseptica ATCC® 13253) and blank (NF reagent) gave a positive reaction where it should have given a negative reaction within the NO3 well of the panel. |
Gan May Ping Quality Manager Thermo Scientific Microbiology Sdn. Bhd. |
|
27 July 2022 |
therascreen® FGFR RGQ RT-PCR KIT |
MDA/FCA/2022-P124 |
IVDC6457619-36847 |
QIAGEN has identified an increased occurrence rate of false positive results obtained with the affected LOTs of the therascreen FGFR RGQ PCR Kit. For a significant percentage of samples with the Overall sample result “FGFR Alteration Detected”, the correct result might be incorrect. Only one individual target, the Amino acid variant p. S249C is not affected. |
DEBRA ANNE ANTHONY PETER SENIOR REGULATORY AFFAIRS MANAGER QIAGEN BIOTECHNOLOGY MALAYSIA SDN BHD |
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27 July 2022 |
FCA Notification related to the bedside panels not being latched as instructed. |
Giraffe Bedded Warmers, Panda iRes Warmers |
MDA/FCA/2022-P125 |
GC18224779718, GC29127486217, GC5981522-82752 |
The Field Safety Notification FMI 32067 (reported date to MDA: 26 Mar 2019) and customer communication, plus enhanced panel design were launched in March 2019 and July 2020, respectively. However, GE Healthcare (GEHC) recently received one complaint of a patient fall related to the bedside panels not being latched as instructed. |
Sharon Lee Regulatory Affairs Assistant GE Healthcare Sdn Bhd |
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28 July 2022 |
NUCLISENS® Magnetic Silica |
MDA/FCA/2022-P126 |
IVDB93265302618 |
Since May 2022, bioMérieux received customer’s complaints for contamination of extraction reagents with Legionella spp nucleic acids using easyMAG® and EMAG® extraction systems. |
Mimi Asmida Ridhwan QA / RA Specialist Biomerieux Malaysia Sdn Bhd |
