BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 10960200 · Received December 7, 2020

    Report

    Report Number
    1119779-2020-01164
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 9, 2020
    Report Date
    September 22, 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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 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. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. NO TREND AGAINST FALSE POSITIVE RESULTS WAS IDENTIFIED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE TESTING FOR SARS-COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. REPEAT TESTING PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).

    Additional Manufacturer Narrative · 1

    EUA # (B)(4). (B)(6). 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. REPEAT TESTING PERFORMED USING PCR TEST METHOD AND THE RESULT WAS NEGATIVE. THERE WAS NO REPORT OF PATIENT IMPACT. EUA # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426795 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