BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR ¿ SARS-COV-2 & FLU A+B

    MDR report key: 13656983 · Received March 2, 2022

    Report

    Report Number
    3006948883-2022-00066
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    February 4, 2022
    Report Date
    July 12, 2024
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING YOUR COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B (MATERIAL # 256088), BATCH NUMBER 1252913. 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. RETURNED PRODUCT TESTING WAS COMPLETED AND ALL DEVICES HAD NORMAL INTENDED RESULTS. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. THE ROOT CAUSE COULD NOT BE IDENTIFIED. NO TREND AGAINST FALSE POSITIVE WAS IDENTIFIED. CURRENTLY NO ADVERSE TREND FOR FALSE POSITIVE WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR ¿ SARS-COV-2 & FLU A+B 2 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. EUA (B)(4). THE FOLLOWING FIELDS WERE CORRECTED WITH ADDITIONAL INFORMATION: " A BD REP REPORTS THIS ISSUE IN BEHALF OF CUSTOMER " BOB MURPHY" THAT THEY ENCOUNTER 4 FALSE POSITIVE FLU RESULTS USING TRIPLES ASSAY "256088" LOT # 1252913".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR ¿ SARS-COV-2 & FLU A+B 2 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. (B)(4). THE FOLLOWING FIELDS WERE CORRECTED WITH ADDITIONAL INFORMATION: " A BD REP REPORTS THIS ISSUE ON BEHALF OF CUSTOMER " BOB MURPHY" THAT THEY ENCOUNTER 4 FALSE POSITIVE FLU RESULTS USING TRIPLES ASSAY "256088" LOT # 1252913"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337849 BD VERITOR ¿ SARS-COV-2 & FLU A+B NOT CLASSIFIED QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 1252913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown