BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 10986207 · Received December 10, 2020

    Report

    Report Number
    1119779-2020-01197
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 22, 2020
    Report Date
    November 26, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QKP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT RAPID DETECTION OF SARS-COV-2 VERITOR (MATERIAL # 256082), BATCH 0233975. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. INVESTIGATIONS WERE PERFORMED ON THE BATCH NUMBER 0233975 AND NO RELEVANT ISSUE WAS FOUND. RETENTION SAMPLE TESTING WAS PERFORMED ON BATCH NUMBER 0233975; NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAINED SAMPLES. A TREND WAS IDENTIFIED FOR FALSE POSITIVE RESULTS. BASED ON THE TREND, CAPA#1878253 WAS INITIATED. 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 WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. CUSTOMER HAS STATED NO ADDITIONAL DETAILS WILL BE PROVIDED. 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 WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. CONFIRMATORY TESTING WAS PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. CUSTOMER HAS STATED NO ADDITIONAL DETAILS WILL BE PROVIDED. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450321 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 0233975

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown