BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 10857609 · Received November 17, 2020

    Report

    Report Number
    8020790-2020-00121
    Event Type
    Malfunction
    Date Received
    November 17, 2020
    Report Date
    February 1, 2021
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN (B)(6) REGARDING POTENTIAL FALSE NEGATIVE RESULTS WHEN TESTING SAMPLES FROM TWO (2) PATIENTS WITH VIDAS® SARS-COV-2 IGM (9COM) 60T REF. 423833 LOT 1008323330. THE CUSTOMER¿S LOT NUMBER USED WAS LATER CORRECTED TO 1008312650 / 210913-0 BASED ON THE VIDAS® REPORT. THE CUSTOMER¿S SAMPLES WERE REQUESTED; HOWEVER, THE SAMPLES WERE UNABLE TO BE SUBMITTED. THE ANALYSIS OF THE BATCH HISTORY RECORD ON VIDAS® SARS-COV-2 IGM REF. 423833 LOT 1008312650 / 210913-0 SHOWED NO ANOMALIES DURING THE MANUFACTURING, QUALITY CONTROL, AND PACKAGING PROCESSES RELATED TO THE SUBJECT OF THIS COMPLAINT. THE COMPLAINT LABORATORY ANALYZED THE RESULTS OF SIX (6) INTERNAL SAMPLES ON SEVEN (7) DIFFERENT BATCHES OF VIDAS® SARS-COV-2 IGM REF. 423833, INCLUDING THE CUSTOMER'S LOT 1008312650 / 210913-0. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS, AND THE CUSTOMER¿S LOT WAS IN THE TREND OF THE OTHER LOTS. THE COMPLAINT LABORATORY TESTED TWO (2) INTERNAL POSITIVE SAMPLES ON THE RETAIN KIT OF THE CUSTOMER'S LOT 1008312650 / 210913-0. THE INTERNAL SAMPLES RESULTS WERE WITHIN THEIR EXPECTED SPECIFICATIONS. THE CUSTOMER¿S ANOMALY WAS NOT REPRODUCED. WITHOUT THE CUSTOMER'S SAMPLE, BIOMÉRIEUX CANNOT PURSUE FURTHER INVESTIGATION OR PROVIDE AN EXPLANATION FOR THIS ISSUE. ACCORDING TO THE INVESTIGATION, VIDAS® SARS-COV-2 IGM REF. 423833 LOT 1008312650 / 210913-0 IS STILL WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) COMPLAINED AFTER HE OBTAINED POTENTIAL FALSE NEGATIVE RESULTS WHEN TESTING SAMPLES FROM TWO (2) SEPARATE PATIENTS WITH VIDAS SARS-COV-2 IGG (9COG) 60T REF. 423834 AND VIDAS SARS-COV-2 IGM (9COM) 60T REF. 423833. THIS MDR IS FOR VIDAS SARS-COV-2 IGM (9COM) 60T REF. 423833 (LOT # 1008323330), PATIENT 1. FOR PATIENT 1 (PATIENT P) : POSITIVE RESULTS WERE OBTAINED WITH ANTIBODY TEST FROM ROCHE (ELECSYS) AND DIASORIN (LIAISON). ADDITIONALLY, THERE WAS A POSITIVE NEUTRALIZATION TEST FROM VIROLOGY, VIENNA. THIS PATIENT HAD A POSITIVE PCR TEST IN THE MEDICAL HISTORY. IT WAS INDICATED THAT THE NEGATIVE RESULTS WERE REPORTED TO THE CLINICIANS. HOWEVER, 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 HAS BEEN INITIATED. NOTE: REFERENCE 423833 IS NOT SOLD OR DISTRIBUTED IN THE UNITED STATES. HOWEVER, U.S-ONLY PRODUCT REFERENCE, 423833-01, HAS THE SAME FORMULATION AND PHYSICAL PROPERTIES AS REFERENCE 423833.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315057 VIDAS SARS-COV-2 IGM VIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008323330

    Patients

    Seq Age Sex Outcome Treatment
    1