BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY

    MDR report key: 10823489 · Received November 11, 2020

    Report

    Report Number
    3006948883-2020-00728
    Event Type
    Malfunction
    Date Received
    November 11, 2020
    Date of Event
    September 29, 2020
    Report Date
    May 18, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EUA#: EUA (B)(4). H6: INVESTIGATION SUMMARY: BD HAS RECEIVED SEVERAL CUSTOMER COMPLAINTS FOR FALSE POSITIVE RESULTS, WHEN USING BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. THE CURRENT INVESTIGATION CONCERNS MULTIPLE LOTS OF BD SARS-COV-2 REAGENTS FOR BD VERITOR¿ SYSTEM. BD TAKES A SYSTEMATIC APPROACH TO INVESTIGATING FALSE POSITIVE COMPLAINTS THAT ARE RECEIVED. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. RETAIN SAMPLES WERE TESTED FOR BATCH #: 0242768. THE DEFECT COULD NOT BE REPLICATED AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0242768. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WERE OBSERVED. IT IS RECOMMENDED THAT EACH CUSTOMER REVIEW THEIR WORKFLOW CAREFULLY TO ENSURE THAT THE PACKAGE INSERT IS BEING FOLLOWED AS WRITTEN. THE ROOT CAUSE IS UNDER INVESTIGATION AND WILL BE DOCUMENTED IN OUR QUALITY SYSTEM. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. A CORRECTIVE AND PREVENTIVE ACTION (CAPA#1878253) IS ALREADY INITIATED TO INVESTIGATE THE ROOT CAUSE AND SOME MITIGATION ACTIONS ARE ALREADY BEING ADDRESSED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE TESTING FOR SARS COV-2 1 FALSE POSITIVE RESULT WAS ALLEGEDLY OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY PCR. ERRONEOUS RESULTS WERE REPORTED OUT AND THE PATIENTS WERE INSTRUCTED TO SELF-QUARANTINE. EUA#: EUA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 1 FALSE POSITIVE RESULT WAS ALLEGEDLY OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY PCR. ERRONEOUS RESULTS WERE REPORTED OUT AND THE PATIENTS WERE INSTRUCTED TO SELF-QUARANTINE. EUA#: EUA (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 1 FALSE POSITIVE RESULT WAS ALLEGEDLY OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY PCR. ERRONEOUS RESULTS WERE REPORTED OUT AND THE PATIENTS WERE INSTRUCTED TO SELF-QUARANTINE. EUA#: EUA (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 4 FALSE POSITIVE RESULTS WERE ALLEGEDLY OBTAINED. CONFIRMATION TESTING WAS PERFORMED BY PCR. ERRONEOUS RESULTS WERE REPORTED OUT, AND THE PATIENTS WERE INSTRUCTED TO SELF-QUARANTINE. EUA#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289785 BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0242768

    Patients

    Seq Age Sex Outcome Treatment
    1