BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10601749 · Received September 29, 2020

    Report

    Report Number
    1119779-2020-00420
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 10, 2020
    Report Date
    August 12, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    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

    EUA # (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. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WAS OBSERVED BY THE USER. IT IS RECOMMENDED THAT EACH CUSTOMER REVIEW THEIR WORKFLOW CAREFULLY TO ENSURE THAT THE PACKAGE INSERT IS BEING FOLLOWED AS WRITTEN. NO RETURN SAMPLES WERE RECEIVED BY THE CUSTOMER. NO RETURN SAMPLE ANALYSIS COULD BE PERFORMED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. 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 4 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND NASOPHARYNGEAL SWAB, THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THE PATIENTS TESTED WERE ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE RESULTS WERE REPORTED TO CLINICIAN AND THE PATIENTS SELF QUARANTINED. EUA # (B)(4).

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. MEDICAL DEVICE LOT #: 0210548 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT #. 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 4 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND NASOPHARYNGEAL SWAB, THE RESULT WAS NEGATIVE. THE CUSTOMER STATED THE PATIENTS TESTED WERE ASYMPTOMATIC. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE RESULTS WERE REPORTED TO CLINICIAN AND THE PATIENTS SELF QUARANTINED. EUA #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065943 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other