BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 11643990 · Received April 9, 2021

    Report

    Report Number
    8020790-2021-00084
    Event Type
    Malfunction
    Date Received
    April 9, 2021
    Report Date
    May 20, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN GREECE REGARDING DISCREPANT RESULTS (SUSPECTED FALSE NEGATIVE) WHEN TESTING A PATIENT SAMPLE WITH VIDAS® SARS-COV-2 IGG (9COG) 60T (REFERENCE#: 423834, LOT: 1008378840). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: ACCORDING TO THE ANALYSIS OF THE QUALITY DATA, NO ANOMALY WAS FOUND DURING THE STAGES OF MANUFACTURE, CONTROL AND PACKAGING. ANALYSIS OF FOUR (4) SAMPLES WERE PERFORMED ON SEVEN (7) BATCHES OF VIDAS SARS COV IGG INCLUDING THE CLIENT BATCH#: 1008378840 / 211020-0. LOT: 211020-0 WAS IN LINE WITH THE OTHER LOTS. THE CUSTOMER WAS UNABLE TO RETURN THE SAMPLE FOR TESTING. THE COMPLAINTS LABORATORY TESTED THREE (3) SERA (2 POSITIVE VT = 1.54 AND 1.75 AND ONE NEGATIVE SERUM VT = 0.65) FROM SEROTHÈQUE S1 152/149 RFV STANDARDS 93-201 RFV ON THE RETAIN KIT OF THE CUSTOMER'S BATCH LOT: 211020-0. THE RESULTS OF THE CALIBRATION WERE CONSISTENT WITH THE MLE LOT DATA. RESULTS WERE COMPLIANT FOR NEGATIVE / POSITIVE SERA AND NO DRIFT WAS OBSERVED FROM VIDAS® SARS-COV-2 IGG 211020-0 LOT. THE CUSTOMER ANOMALY IS NOT REPRODUCED AT THE COMPLAINTS LABORATORY BY TESTING POSITIVE SERA. FURTHER INVESTIGATION CANNOT BE PERFORMED WITHOUT THE RETURN OF THE CUSTOMER'S SAMPLE. ACCORDING TO THE DATA MENTIONED ABOVE, VIDAS SARS-COV-2 IGG (REFERENCE: 423834, BATCH: 1008378840 / 211020-0) IS PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING DISCREPANT RESULTS (SUSPECTED FALSE NEGATIVE) WHEN TESTING A PATIENT SAMPLE WITH VIDAS® SARS-COV-2 IGG (9COG) 60T (REFERENCE #:423834, LOT 1008378840). THE (B)(6) PATIENT WAS TESTED TWO (2) MONTHS AFTER HAVING COVID-19 TO CHECK THE IGG ANTIBODIES LEVEL. THE SAME SAMPLE WAS TESTED AND GAVE THE FOLLOWING RESULTS : VIDAS SARS-COV-2 IGG GAVE A NEGATIVE RESULT (TV 0.76 AND 0.81). TEST WITH CLIA METHOD GAVE A POSITIVE RESULT (25 WITH CUTOFF 1.4). RAPID ANTIBODY TEST GAVE A POSITIVE RESULT. IT WAS INDICATED THAT THE CUSTOMER HANDLED PROPERLY THE SAMPLE AND 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. IT SHOULD BE NOTED THAT THE PRINTED TEST SLIPS WITH THE RESULTS FROM THE MINIVIDAS® INDICATED THAT THERE WAS "INSUFFICIENT STANDARD RUN OR STANDARD VALUE OUT OF RANGE". GLOBAL CUSTOMER SERVICE (GCS) RECOMMENDED TESTING THE SAMPLE WITH A VALID CALIBRATION. HOWEVER, NO REMAINING SAMPLE WAS AVAILABLE. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540508 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008378840

    Patients

    Seq Age Sex Outcome Treatment
    1