BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10703502 · Received October 20, 2020

    Report

    Report Number
    3006948883-2020-00572
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 24, 2020
    Report Date
    October 14, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH NUMBER 0242768. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE/DISCREPANT RESULTS COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. INITIATED. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. HOWEVER, THERE IS A TREND AGAINST FALSE POSITIVE RESULTS. BD HAS INITIATED CAPA (CORRECTIVE AND PREVENTIVE ACTION) # (B)(4) TO FURTHER INVESTIGATE. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY THREE (3) FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING A PCR TEST METHOD AND THE RESULTS WERE 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. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. 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 THREE (3) FALSE POSITIVE RESULTS WERE OBTAINED. REPEAT TESTS WERE PERFORMED USING A PCR TEST METHOD AND THE RESULTS WERE 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. THERE WAS NO REPORT OF PATIENT IMPACT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173985 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0242768

    Patients

    Seq Age Sex Outcome Treatment
    1 Other