BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11399001 · Received March 2, 2021

    Report

    Report Number
    8020790-2021-00020
    Event Type
    Malfunction
    Date Received
    March 2, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN MOROCCO REGARDING FALSE NEGATIVE RESULT WHILE TESTING THREE (3) PATIENT STRAINS FROM SEPARATE PATIENTS USING THE VIDAS® SARS-COV-2 IGG TEST KIT (REFERENCE # (B)(4), LOT # 1008344690). THE CUSTOMER STATED IT WAS KNOWN THAT THE PATIENTS HAD COVID-19; HOWEVER, THE VIDAS® SARS-COV-2 IGG RESULTS WERE NEGATIVE WHEN COMPARED TO OTHER METHODS. NOTE: REFERENCE (B)(4) IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, (B)(4), HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE (B)(4). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: THE CUSTOMER DID NOT HAVE ANY REMAINING SAMPLES TO BE RETURNED FOR INVESTIGATION. ACCORDING TO QUALITY CONTROL RECORDS, THERE IS NO ANOMALY HIGHLIGHTED DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES ON VIDAS SARS COV-2 IGG LOT 1008344690/210924-0. THE COMPLAINTS LABORATORY PERFORMED A CONTROL CHART ANALYSIS ON FOUR (4) INTERNAL SAMPLES WITH A POSITIVE TARGET. THE SAMPLES WERE TESTED ON SEVEN (7) BATCHES OF VIDAS SARS COV-2 IGG INCLUDING THE LOT MENTIONED BY CUSTOMER 1008344690/210924-0. THE ANALYSIS SHOWED THAT THE SAMPLES COMPLIED WITH THE EXPECTATIONS AND VIDAS SARS COV-2 IGG BATCH 1008344690/210924-0 IS IN THE TREND COMPARED TO THE OTHER LOTS. THE COMPLAINTS LABORATORY PERFORMED A TEST ON FOUR (4) INTERNAL SAMPLES (3 WITH A POSITIVE TARGET AND 1 WITH A NEGATIVE TARGET). THE SAMPLE RESULTS COMPLIED WITH THE EXPECTED SPECIFICATIONS WITHOUT ANY SIGNIFICANT DIFFERENCE COMPARED TO THE RESULTS OBSERVED BEFORE THE BATCH RELEASE. THEREFORE, NO EVOLUTION WAS OBSERVED OVER TIME OF VIDAS SARS COV-2 IGG BATCH 1008344690/210924-0. THE CUSTOMER'S NEGATIVE RESULTS WERE NOT REPRODUCED ON THE VIDAS SARS COV-2 IGG WHEN TESTING POSITIVE INTERNAL SAMPLES ON VIDAS SARS COV-2 IGG BATCH 1008344690/210924-0. ALL THE RESULTS COMPLIED WITH EXPECTATIONS. WITHOUT ANY CONCERNED SAMPLE AVAILABLE, IT WAS NOT POSSIBLE TO PURSUE FURTHER INVESTIGATION. THEREFORE, A ROOT CAUSE WAS NOT DETERMINED. IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS SARS COV-2 IGG REF.(B)(4) AT THE SECTION LIMITATIONS OF THE METHOD: " - RESULTS OBTAINED USING SAMPLES FROM SARS-COV-2 INFECTED PATIENTS MUST BE INTERPRETED WITH CAUTION. - THE INDIVIDUAL IMMUNE RESPONSE FOLLOWING SARS-COV-2 INFECTION VARIES CONSIDERABLY AND MIGHT GIVE DIFFERENT RESULTS WITH ASSAYS FROM DIFFERENT MANUFACTURERS. RESULTS OF ASSAYS FROM DIFFERENT MANUFACTURERS SHOULD NOT BE USED INTERCHANGEABLY." THE VIDAS SARS COV-2 IGG REF.(B)(4) LOT 1008344690/210924-0 IS MEETING ITS SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT WHILE TESTING THREE (3) PATIENT STRAINS FROM SEPARATE PATIENTS USING THE VIDAS® SARS-COV-2 IGG TEST KIT (REFERENCE # 423834, LOT # 1008344690). THE CUSTOMER STATED IT WAS KNOWN THAT THE PATIENTS HAD COVID-19; HOWEVER, THE VIDAS® SARS-COV-2 IGG RESULTS WERE NEGATIVE WHEN COMPARED TO OTHER METHODS. 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. VIDAS® SARS-COV-2 IGG: NEGATIVE. RT PCR: POSITIVE. RAPID TEST (IGG):POSITIVE. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL DETAILS DESPITE MULTIPLE ATTEMPTS BY CUSTOMER SERVICE. 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 BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296974 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008344690

    Patients

    Seq Age Sex Outcome Treatment
    1