BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10666404 · Received October 12, 2020

    Report

    Report Number
    3006948883-2020-00545
    Event Type
    Malfunction
    Date Received
    October 12, 2020
    Date of Event
    September 15, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINTS THAT ALLEGES FALSE NEGATIVE OR DISCREPANT RESULTS WHEN USING KIT BD VERITOR FOR RAPID DETECTION OF SARS-COV-2 (MN# 256082), BATCH NUMBER 0213905 BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE NEGATIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY A FALSE NEGATIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULT WAS POSITIVE. THE CUSTOMER STATED THE EMPLOYEE TESTED WAS ASYMPTOMATIC WITH KNOWN EXPOSURE. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE EMPLOYEE SELF QUARANTINED AND THE RESIDENTS HAD TO BE TESTED. EUA # (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 THAT WHILE USING BD RAPID DETECTION OF SARS-COV-2 VERITOR ASSAY A FALSE NEGATIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING A PCR TEST METHOD AND THE RESULT WAS POSITIVE. THE CUSTOMER STATED THE EMPLOYEE TESTED WAS ASYMPTOMATIC WITH KNOWN EXPOSURE. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THE EMPLOYEE SELF QUARANTINED AND THE RESIDENTS HAD TO BE TESTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131566 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0213905

    Patients

    Seq Age Sex Outcome Treatment
    1 Other