BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR

    MDR report key: 12542403 · Received September 28, 2021

    Report

    Report Number
    1119779-2021-01585
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 2, 2021
    Report Date
    December 23, 2021
    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

    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 1153341. 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. A BHR REVIEW WAS PERFORMED ON THE BATCH NUMBER PROVIDED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. RETENTION TESTING COULD NOT BE PERFORM BECAUSE THE PRODUCT HAS EXPIRED. RETURNED TESTING RESULTS WERE VALID AND ACCURATE AND COMPLAINT COULD NOT 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. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. PATIENTS WERE QUARANTINED UNTIL PCR RESULTS WERE RECEIVED, THERE WAS NO PATIENT IMPACT OTHERWISE NOTED. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT ANALYZER DISPLAYED FALSE POSITIVE RESULT."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE TESTING FOR SARS COV-2 A FALSE POSITIVE RESULT WAS OBTAINED. A REPEAT TEST WAS PERFORMED USING PCR AND THE RESULT WAS NEGATIVE. PATIENTS WERE QUARANTINED UNTIL PCR RESULTS WERE RECEIVED, THERE WAS NO PATIENT IMPACT OTHERWISE NOTED. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: '' IT WAS REPORTED THAT ANALYZER DISPLAYED FALSE POSITIVE RESULT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1438475 BD RAPID DETECTION OF SARS-COV-2 VERITOR CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BECTON, DICKINSON & CO. (SPARKS) 1153341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown