BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SARS-COV-2 AND FLU A+B

    MDR report key: 12704336 · Received October 27, 2021

    Report

    Report Number
    3006948883-2021-00990
    Event Type
    Malfunction
    Date Received
    October 27, 2021
    Date of Event
    September 29, 2021
    Report Date
    January 13, 2022
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 1189936 AND 1182888. 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. A PHOTOGRAPH WAS RETURNED AND SHOWED BD VERITOR¿ SARS-COV-2 AND FLU A+B ANALYZER DISPLAYED FLU A +, FLU B: - AND COV2: - AND UNABLE TO CONFIRM OF REPORTED FALSE POSITIVE RESULTS. THE REPORTED COMPLAINT WAS UNABLE TO BE CONFIRMED. 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 THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B 12 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THERE WERE 12 FALSE POSITIVES FOR FLU A USING THE TRIPLEX ASSAY. "

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER: ADDRESS UNAVAILABLE. (B)(6) ADDRESS USED. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1189936. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2021-07-08. MEDICAL DEVICE LOT #: 1189936. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B 12 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THERE WERE 12 FALSE POSITIVES FOR FLU A USING THE TRIPLEX ASSAY. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1602736 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown