BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10712752 · Received October 21, 2020

    Report

    Report Number
    3006948883-2020-00587
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    October 10, 2020
    Report Date
    April 28, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 FOR BATCH NUMBER 0221748, TESTING OF RETENTION SAMPLES OF BATCH NUMBER 0221748, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. THE INVESTIGATION DID NOT FIND A ROOT CAUSE FOR THE FALSE POSITIVE RESULTS THAT WAS OBSERVED. 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 3 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND 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 FALSE POSITIVE RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY 3 FALSE POSITIVE RESULTS WERE OBTAINED. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND 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 FALSE POSITIVE RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176272 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0221748

    Patients

    Seq Age Sex Outcome Treatment
    1