BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGG

    MDR report key: 10615426 · Received October 1, 2020

    Report

    Report Number
    8020790-2020-00094
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Report Date
    March 12, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN INDIA REGARDING A FALSE NEGATIVE RESULT WHILE TESTING A PATIENT STRAIN USING THE VIDAS® SARS-COV-2 IGG (REF 423834, BATCH 1008197250, EXPIRY DATE 08-JUL-2021). A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: THERE WAS NO SAMPLE LEFT TO BE RETURNED BY THE CUSTOMER. ACCORDING TO QUALITY CONTROL RECORDS, THERE WAS NO ANOMALY OBSERVED DURING THE MANUFACTURING, QUALITY CONTROL AND PACKAGING PROCESSES. AN ANALYSIS OF FOUR (4) INTERNAL POSITIVE SERA WAS PERFORMED ON ALL BATCHES SINCE THE MARKETING OF THE VIDAS SARS COV-2 IGG KIT INCLUDING THE CUSTOMER'S BATCH (1008197250 / 210708-1). THE ANALYSIS SHOWED THAT THE SAMPLES COMPLY WITH THE EXPECTATIONS AND VIDAS SARS COV-2 IGG BATCH 1008197250 / 210708-1 WAS IN THE TREND COMPARED TO THE OTHER LOTS. THE INVESTIGATION UNIT LABORATORY TESTED SAMPLES TWO (2) WITH POSITIVE TARGET AND TWO (2) WITH NEGATIVE TARGET) ON PV VIDAS SARS COV 2 IGG KITS (1008197250 / 210708-1). THE RESULTS OF THE CALIBRATION WERE IN ACCORDANCE WITH THE MLE LOT DATA. COMPLIANT RESULTS FOR THE NEGATIVE AND POSITIVE SERA WERE OBTAINED WITH VALUES NOT SIGNIFICANTLY DIFFERENT FROM THOSE OBSERVED DURING THE BATCH CONTROL. NO DRIFT WAS OBSERVED FOR VIDAS SARS COV 2 IGG KITS (1008197250 / 210708-1). THE RESULTS WERE SIMILAR TO THOSE OBTAINED DURING THE RELEASE. EXTERNAL QUALITY ASSESSMENT AND CAP SURVEY SAMPLES (2 POSITIVE SAMPLES AND A NEGATIVE ONE) WERE TESTED ON SEVERAL BATCHES OF VIDAS SARS COV-2 IGG INCLUDING THE CUSTOMER'S LOT (1008197250 / 210708-1). ALL THE RESULTS WERE COMPLIANT TO EXPECTED INTERPRETATION WITH SIMILAR LEVELS AMONG ALL LOTS TESTED. 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 KITS (1008197250 / 210708-1) IS FUNCTIONING AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF OBTAINING A FALSE NEGATIVE RESULT WHILE TESTING A PATIENT STRAIN USING THE VIDAS® SARS-COV-2 IGG (REF 423834, BATCH 1008197250, EXPIRY DATE 08-JUL-2021). THE RESULTS WERE AS FOLLOWS: VIDAS SARS-COV-2 IGG: RESULT 1: TV = 0.68 (NEGATIVE INTERPRETATION), VIDAS SARS-COV-2 IGG: RESULT 2: TV = 0.53 (NEGATIVE INTERPRETATION), AND VIDAS SARS-COV-2 IGM: RESULT: TV = 7.84 (POSITIVE INTERPRETATION). OTHER METHODS WERE USED TO TEST THE SAME PATIENT SAMPLE AND THE RESULTS WERE AS FOLLOWS: ROCHE METHOD (SARS COV2 TOTAL ANTIBODIES): POSITIVE INTERPRETATION. ABBOTT-ARCHITECT METHOD (DETECTS IGG AGAINST NUCLEOCAPSID): POSITIVE INTERPRETATION. RESULT INTERPRETATION: <12: NEGATIVE ; 12-15: EQUIVOCAL ; >15: POSITIVE). VALUE = 16.9 AU/ML, RT-PCR = 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 BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE 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
    1077490 VIDAS SARS-COV-2 IGG VIDAS® SARS-COV-2 IGG QKO BIOMERIEUX SA 1008197250

    Patients

    Seq Age Sex Outcome Treatment
    1