BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10570515 · Received September 22, 2020

    Report

    Report Number
    1119779-2020-00384
    Event Type
    Malfunction
    Date Received
    September 22, 2020
    Date of Event
    September 15, 2020
    Report Date
    May 6, 2021
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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 #: 0210548. THE DEFECT COULD NOT BE REPLICATED AND THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0210548. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THE PATIENT TESTED WAS ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. ERRONEOUS RESULTS WERE REPORTED OUT, AND THE PATIENT WAS SENT HOME TO WAIT FOR THE PCR RESULTS. THERE WAS NO PATIENT IMPACT REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). MEDICAL DEVICE LOT #: 0210548 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT #. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THE PATIENT TESTED WAS ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. ERRONEOUS RESULTS WERE REPORTED OUT, AND THE PATIENT WAS SENT HOME TO WAIT FOR THE PCR RESULTS. THERE WAS NO PATIENT IMPACT REPORTED. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035746 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other