BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS SARS-COV-2 IGM

    MDR report key: 10209442 · Received June 29, 2020

    Report

    Report Number
    8020790-2020-00053
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Report Date
    August 20, 2020
    Manufacturer
    BIOMERIEUX SA
    Product Code
    QKO
    PMA / PMN Number
    UNCLASSIFIED
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CUSTOMER IN ITALY NOTIFIED BIOMÉRIEUX OF A BARCODE ERROR IN ASSOCIATION WITH VIDAS® SARS-COV-2 IGM (REF. 423833-02, BATCH 1008090850). THE CUSTOMER¿S VIDAS® 3 INSTRUMENT DID NOT RECOGNIZE THE VIDAS® SARS-COV-2 IGM BATCH 1008090850 BAR CODE, AN ERROR MESSAGE STATING THE SAME LOT ALREADY EXISTS IN MEMORY WAS OBTAINED. IN RESPONSE TO THE CUSTOMER COMPLAINT BIOMÉRIEUX CONDUCTED AN INTERNAL INVESTIGATION. BIOMÉRIEUX REQUESTED THE CUSTOMER¿S BACKUP DATA AS WELL AS THE CALIBRATION AND ALARM EXPORTS; HOWEVER, THIS INFORMATION WAS NOT PROVIDED. BIOMÉRIEUX READ THE MLE DATA ON A VIDAS® 3 INSTRUMENT AND PERFORMED A CALIBRATION USING THE VIDAS® SARS COV-2 IGM PV KIT 1008090850 / 210509-0. THE CUSTOMER¿S ANOMALY WAS NOT REPRODUCED DURING THE CALIBRATION. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT THE CUSTOMER¿S DATA. BASED UPON THE RESULTS OBTAINED BY BIOMÉRIEUX, VIDAS® SARS COV-2 IGM PV KIT 1008090850 / 210509-0 IS PERFORMING WITHIN SPECIFICATION. SEE SECTION H10.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF A BARCODE ERROR IN ASSOCIATION WITH VIDAS® SARS-COV-2 IGM (REF. 423833-02, BATCH 1008090850). THE CUSTOMER¿S VIDAS® 3 INSTRUMENT DID NOT RECOGNIZE THE VIDAS® SARS-COV-2 IGM BATCH 1008090850 BAR CODE, AN ERROR MESSAGE STATING THE SAME LOT ALREADY EXISTS IN MEMORY WAS OBTAINED. RECALIBRATION OF BATCH 1008090850 ON THEIR VIDAS® 3 INSTRUMENT WAS ATTEMPTED; THE SAME BAR CODE ERROR MESSAGE WAS OBSERVED. THE CUSTOMER THEN TESTED SARS-COV-2 IGM BATCH 1008090850 USING A VIDAS® PC INSTRUMENT, NO ERROR MESSAGE WAS OBSERVED. THE CUSTOMER STATED THE ERROR MESSAGES LEAD TO A DELAY IN REPORTING PATIENT RESULTS; THE CUSTOMER HAS NOT PROVIDED ANY ADDITIONAL DETAIL REGARDING THE DURATION OF THE DELAY. BIOMÉRIEUX HAS MADE MULTIPLE ATTEMPTS REQUESTING THE CUSTOMER¿S SYSTEM DATA TO AID IN TROUBLE SHOOTING, AND HAS NOT YET RECEIVED A RESPONSE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DELAY LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. BIOMÉRIEUX HAS INITIATED AN INTERNAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674397 VIDAS SARS-COV-2 IGM VIDVIDAS® SARS-COV-2 IGM QKO BIOMERIEUX SA 1008090850

    Patients

    Seq Age Sex Outcome Treatment
    1