BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 16273592 · Received January 31, 2023

    Report

    Report Number
    1119779-2023-00089
    Event Type
    Malfunction
    Date Received
    January 31, 2023
    Date of Event
    January 26, 2023
    Report Date
    February 27, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE NEGATIVE RESULT WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 2242261. 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. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. RESULTS WERE ACCEPTABLE AND NO RELEVANT ISSUE WAS FOUND. ACCORDING TO THE CUSTOMER, VERITOR CARTRIDGE GAVE A NEGATIVE RESULT ON THE ANALYZER BUT WHEN THEY READ IT VISUALLY IT SEEMS POSITIVE FOR FLU A, THEN AFTER SOME MINUTES THEY REINTRODUCED THE CARTRIDGE INTO THE ANALYZER AND GAVE A POSITIVE RESULT. BASED ON THE PROVIDED INFORMATION, IT WAS UNDERSTOOD THAT THE CUSTOMER REINSERTED THE SAME CARTRIDGE INTO THE ANALYZER, WHICH IS NOT RECOMMENDED BY BD. BD REPRESENTATIVE ADVISED THE CUSTOMER THAT THIS TEST IS NOT INTENDED FOR VISUAL READING, AND THEY SHOULD NOT BE REINTRODUCING THE SAME CARTRIDGE TO THE ANALYZER AFTER THE SET POINT, BECAUSE THIS IS AN OUT OF LABEL USE. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED. CURRENTLY NO ADVERSE TREND FOR FALSE NEGATIVE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B THAT THERE WAS FALSE NEGATIVE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERITOR 256088 CUSTOMER STATES FALSE NEGATIVE RESULT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VERITOR ¿ SARS-COV-2 & FLU A+B THAT THERE WAS FASLE NEGATIVE RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERITOR 256088 CUSTOMER STATES FALSE NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790450 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BECTON, DICKINSON & CO. (SPARKS) 2242261

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown