BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B

    MDR report key: 21682377 · Received March 24, 2025

    Report

    Report Number
    3006948883-2025-00013
    Event Type
    Malfunction
    Date Received
    March 24, 2025
    Date of Event
    February 14, 2025
    Report Date
    May 8, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QMN
    UDI-DI
    00382902560883
    PMA / PMN Number
    SEE H.11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY - THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE (MULTIPLE LINES PRESENT) WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASSAY (MATERIAL#: 256088), BATCH NUMBER 4190377. THE CUSTOMER REPORTED THAT THEY RECEIVED ALL POSITIVE RESULTS FOR COVID, FLU A AND FLU B ON A PATIENT SAMPLE. THEY RETESTED THE PATIENT WITH THE STANDALONE COVID AND FLU TEST, AND THE RESULTS WERE NEGATIVE. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, VISUAL INSPECTION OF RETENTION SAMPLES, AND VISUAL INSPECTION OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. BATCH HISTORY RECORD (BHR) REVIEW AND RETAIN SAMPLE TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED. BHR REVIEW WAS ACCEPTABLE AND NO RELEVANT ISSUES WERE FOUND. THE REPORTED ISSUE WAS NOT CONFIRMED THROUGH RETAIN TESTING, SINCE THE RETAIN SAMPLE TESTING DID NOT CORROBORATE THE CUSTOMER'S ISSUE OF POSITIVE FOR FLU A, FLU B AND COVID. NO SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, THERE WERE PHOTOS PROVIDED. FROM THE PHOTOS PROVIDED SHOWING THE DEVICES, THERE IS A VISIBLE POSITIVE CONTROL LINE, COVID TEST LINE, AND AN ADDITIONAL LINE BELOW THE FLU A LINE. THIS ADDITIONAL LINE BELOW THE FLU A LINE IS THE NEGATIVE CONTROL (NC) LINE AND IS UNMARKED ON THE CARTRIDGE. THE NC LINE FUNCTIONS TO BIND WITH INTERFERING ANTIBODIES THAT MAY BE PRESENT IN A SAMPLE AND WILL REDUCE THE CHANCES OF THESE INTERFERING ANTIBODIES TO BIND TO THE OTHER TEST LINES. SINCE THE POSITIVE CONTROL (PC) LINE IS VISIBLE IN ALL PHOTOS RECEIVED, THE TESTS ARE VALID AND THE ASSAY IS THEREFORE FUNCTIONING AS EXPECTED. THE PHOTO OF VERITOR ANALYZER RESULT WAS NOT PROVIDED. THUS, THE REPORTED ISSUE WAS NOT CONFIRMED. BASED ON THIS, THE REPORTED ISSUE MAY BE A SAMPLE ISSUE AND IT IS RECOMMENDED THAT THE CUSTOMER USE A DIFFERENT TESTING METHODOLOGY IF THIS ISSUE REOCCURS. A TREND ANALYSIS FOR FALSE POSITIVE (MULTIPLE LINES PRESENT) WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE 510K IS AS FOLLOWS: G4. PMA/510(K)#: EUA: (B)(4). 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

    REPORT 2 OF 2: IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 AND FLU A+B, ONE (1) POSITIVE PATIENT RESULT FOR COVID AND FLU A/B WAS OBTAINED. REPEAT TESTING WAS PERFORMED ON THE VERITOR ANALYZER WITH A NEW SAMPLE AND RESULTS WERE REPORTED TO BE CONFLICTING/DIFFERENT. IN ADDITION, RETESTING USING A NEW SAMPLE WAS PERFORMED WITH INDIVIDUAL TESTS FOR COVID AND FLU A/B, AND THE PATIENT WAS NEGATIVE FOR COVID AND FLU A/B. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA (B)(4).

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, ONE (1) POSITIVE PATIENT RESULT FOR COVID AND FLU A/B WAS OBTAINED. REPEAT TESTING WAS PERFORMED ON THE VERITOR ANALYZER WITH A NEW SAMPLE AND RESULTS WERE REPORTED TO BE CONFLICTING/DIFFERENT. IN ADDITION, RETESTING USING A NEW SAMPLE WAS PERFORMED WITH INDIVIDUAL TESTS FOR COVID AND FLU A/B, AND THE PATIENT WAS NEGATIVE FOR COVID AND FLU A/B. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. EUA: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753230 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B ANTIGEN DETECTION REAGENT KIT QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4190377 00382902560883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown