BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 11131699 · Received January 7, 2021

    Report

    Report Number
    3006948883-2021-00031
    Event Type
    Malfunction
    Date Received
    January 7, 2021
    Date of Event
    December 8, 2020
    Report Date
    October 11, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0273077. D.4. MEDICAL DEVICE EXPIRATION DATE: 2/24/2021. H.4. DEVICE MANUFACTURE DATE: 9/29/2020. H.6. INVESTIGATION: THIS STATEMENT 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# (B))(4)), BATCH NUMBER UNKNOWN. 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. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS OF RETENTION MATERIALS MET ACCEPTANCE CRITERIA. NO RETURNS WERE RECEIVED TO INVESTIGATE. QUALITY WAS UNABLE TO DUPLICATE THE CUSTOMERS REPORTED FAILURE MODE. 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 DURING VALIDATION TESTING FOR SARS-COV-2 FIVE (5) DISCREPANT RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD. THE CUSTOMER STATED THEY ARE TESTING BOTH SYMPTOMATIC AND ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).

    Additional Manufacturer Narrative · 1

    EUA # (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 DURING VALIDATION TESTING FOR SARS-COV-2 FIVE (5) DISCREPANT RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD. THE CUSTOMER STATED THEY ARE TESTING BOTH SYMPTOMATIC AND ASYMPTOMATIC PATIENTS. THIS TEST IS NOT INTENDED FOR USE ON ASYMPTOMATIC PATIENTS AND WAS THEREFORE USED OFF LABEL. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27010 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 0273077

    Patients

    Seq Age Sex Outcome Treatment
    1