BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10597574 · Received September 28, 2020

    Report

    Report Number
    1119779-2020-00415
    Event Type
    Malfunction
    Date Received
    September 28, 2020
    Date of Event
    September 3, 2020
    Report Date
    March 9, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL AND CORRECTED INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. ¿ SUZHOU, CHINA / 215021 D.4. MEDICAL DEVICE LOT #: 0222901. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-01-27. G.2 MANUFACTURING LOCATION: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. ¿ SUZHOU, CHINA / 215021. H.4. DEVICE MANUFACTURE DATE: 2020-08-21.

    Additional Manufacturer Narrative · 0

    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. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0222901. 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.

    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. SOME OF THE POSITIVE SAMPLES WERE REPEATED ON THE VERITOR AND GAVE DISCREPANT RESULTS. SAMPLES WERE SENT FOR PCR TESTING AND WERE NEGATIVE. TESTING PERFORMED WAS PERFORMED ON STAFF AND THE ERRONEOUS RESULTS RESULTED IN A 10 DAY QUARANTINE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. EUA # 201889.

    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. SOME OF THE POSITIVE SAMPLES WERE REPEATED ON THE VERITOR AND GAVE DISCREPANT RESULTS. SAMPLES WERE SENT FOR PCR TESTING AND WERE NEGATIVE. TESTING PERFORMED WAS PERFORMED ON STAFF AND THE ERRONEOUS RESULTS RESULTED IN A 10 DAY QUARANTINE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. EUA # (B)(4).

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). MEDICAL DEVICE LOT #: 012266(02) WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED BY BD. 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 4 FALSE POSITIVE RESULTS WERE OBTAINED. SOME OF THE POSITIVE SAMPLES WERE REPEATED ON THE VERITOR AND GAVE DISCREPANT RESULTS. SAMPLES WERE SENT FOR PCR TESTING AND WERE NEGATIVE. TESTING PERFORMED WAS PERFORMED ON STAFF AND THE ERRONEOUS RESULTS RESULTED IN A 10 DAY QUARANTINE. THE CUSTOMER STATED THEY ARE TESTING ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1059413 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0222901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other