BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11133735 · Received January 7, 2021

    Report

    Report Number
    8020790-2021-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Report Date
    March 18, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN THE (B)(6) REGARDING A FALSE NEGATIVE RESULT WHILE TESTING A PATIENT STRAIN USING THE VIDAS® SARS-COV-2 IGG (REFERENCE # 423834, LOT # 1008117720). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: THE CUSTOMER'S SAMPLE WAS NOT AVAILABLE TO BE TESTED. AN ANALYSIS OF THE BATCH HISTORY RECORD OF VIDAS SARS COV-2 IGG (LOT 1008117720/210529-0) SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. THE COMPLAINTS LABORATORY PERFORMED A STUDY OF INTERNAL SAMPLES CONTROL CHARTS WAS CARRIED OUT ON FOUR (4) INTERNAL POSITIVES SERA (TARGETS BETWEEN 1.34 TV AND 2.23 TV) ON SEVEN (7) BATCHES INCLUDING THE LOT MENTIONED BY THE CUSTOMER. ALL VALUES WERE WITHIN SPECIFICATION AND THE CUSTOMER'S LOT WAS IN TREND WITH THE OTHER LOTS. THE COMPLAINTS LABORATORY TESTED FOUR (4) INTERNAL SAMPLES (THREE (3) WITH POSITIVE TARGETS AND ONE (1) NEGATIVE) ON THE RETAIN KIT VIDAS SARS COV-2 IGG (LOT 1008117720/210529-0). ALL SAMPLE RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBSERVED BEFORE THE BATCH RELEASE. NO DRIFT WAS OBSERVED FOR VIDAS SARS COV-2 IGG (LOT 1008117720/210529-0). EXTERNAL QUALITY ASSESSMENT AND CAP SURVEY SAMPLES WERE TESTED AND FOR THE FOUR (4) SAMPLES TESTED, THE RESULTS FOUND FOR THE VIDAS SARS-COV-2 IGG SAMPLES WERE CONSISTENT WITH THE ASSIGNED RESULTS. THE CUSTOMER ANOMALY WAS NOT REPRODUCED AT THE COMPLAINTS LABORATORY BY TESTING POSITIVE SERA. WITHOUT A PATIENT SAMPLE, IT IS NOT POSSIBLE TO FURTHER INVESTIGATE THE CUSTOMER'S ISSUE. THE DATA REVIEW CONCLUDES THAT VIDAS® SARS-COV-2 IGG (LOT 1008117720/210529-0) IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN THE (B)(6) NOTIFIED BIOM¿RIEUX OF OBTAINING A FALSE NEGATIVE RESULT WHILE TESTING A PATIENT STRAIN USING THE VIDAS¿ SARS-COV-2 IGG (REFERENCE # 423834, LOT # 1008117720). NOTE: REFERENCE 423834 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423834-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423834. THE CUSTOMER OBTAINED A POSITIVE PCR RESULT PRIOR TO (B)(6) 2020; HOWEVER, THE EXACT DATE WAS NOT SPECIFIED. ON (B)(6) 2020, VIDAS¿ SARS-COV-2 IGG - 0.65, NEGATIVE. VIDAS¿ SARS-COV-2 IGM - 1.45, POSITIVE. ON (B)(6) 2020, PCR NEGATIVE VIDAS¿ SARS-COV-2 IGG - 0.62, NEGATIVE. VIDAS¿ SARS-COV-2 IGM - 0.69, NEGATIVE. MINDRAY IGG - POSITIVE ON (B)(6) 2020 - RETEST OF (B)(6) 2020 SAMPLE VIDAS¿ SARS-COV-2 IGG - 0.71, NEGATIVE. THE CUSTOMER SENT THE TWO SAMPLES TO A REFERENCE LAB WHERE THE SARS-COV-2 IGG RESULTS WERE POSITIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. A BIOM¿RIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26657 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008117720

    Patients

    Seq Age Sex Outcome Treatment
    1