BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 12821748 · Received November 16, 2021

    Report

    Report Number
    1119779-2021-01825
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 14, 2021
    Report Date
    March 1, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), INVALID BATCH NUMBER 1152165. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION COULD NOT BE PERFORMED AS AN INVALID BATCH NUMBER 1152165 WAS PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THERE ARE NO CURRENT TRENDS FALSE POSITIVE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 3 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO PATIENT IMPACT. (B)(4). CUSTOMER REPORTED THAT SHE GOT 3 FALSE POSITIVE RESULTS USING THE BD RAPID SARS-COV-2 KIT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 3 FALSE POSITIVE RESULTS WERE OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULTS WERE NEGATIVE. THERE WAS NO PATIENT IMPACT. EUA # (B)(4). CUSTOMER REPORTED THAT SHE GOT 3 FALSE POSITIVE RESULTS USING THE BD RAPID SARS-COV-2 KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1720986 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown