BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12515770 · Received September 22, 2021

    Report

    Report Number
    3006948883-2021-00942
    Event Type
    Malfunction
    Date Received
    September 22, 2021
    Date of Event
    August 26, 2021
    Report Date
    December 20, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING THE COMPLAINT THAT ALLEGES FALSE POSITIVE PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE FALSE POSITIVE COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. THE COMPLAINT WAS UNABLE TO BE CONFIRMED. THERE ARE NO CURRENT TRENDS AGAINST FALSE POSITIVE. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTIONS: D.2. PRODUCT CODE: QMN; COMMON DEVICE NAME: NOT CLASSIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A RAPID CARD TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER IS RECEIVING FALSE POSITIVE FLU A RESULT WITH TRIPLEX TEST. CONFIRMED BY USING A RAPID CARD METHOD"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A RAPID CARD TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA# (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER IS RECEIVING FALSE POSITIVE FLU A RESULT WITH TRIPLEX TEST. CONFIRMED BY USING A RAPID CARD METHOD."

    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 THAT WHILE USING BD VERITOR¿ SARS-COV-2 AND FLU A+B A FALSE POSITIVE RESULT WAS OBTAINED BY THE LABORATORY PERSONNEL. A RAPID CARD TEST WAS USED TO CONFIRM THE RESULTS AS FALSE POSITIVES. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. EUA#: (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT CUSTOMER IS RECEIVING FALSE POSITIVE FLU A RESULT WITH TRIPLEX TEST. CONFIRMED BY USING A RAPID CARD METHOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410545 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1193294
    1410554 BD VERITOR¿ SARS-COV-2 AND FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1193294

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown