BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 22939705 · Received September 2, 2025

    Report

    Report Number
    3006948883-2025-00606
    Event Type
    Malfunction
    Date Received
    September 2, 2025
    Date of Event
    November 25, 2024
    Report Date
    July 10, 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
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. G4. PMA/510(K)#: EUA# (B)(4). H4. DEVICE MANUFACTURE DATE: UNKNOWN. THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASS (MATERIAL#: 256088), BATCH NUMBER 4190377 AND UNKNOWN. THE CUSTOMER REPORTED THAT THEY RECEIVED FALSE POSITIVE RESULTS FROM THE ANALYZER. ONE SPECIMEN WAS RECOLLECTED FOR PCR TESTING, WHICH RETURNED AS A NEGATIVE RESULT. HOWEVER, THEY ARE UNABLE TO CONFIRM THE LOT NUMBER ASSOCIATED WITH THIS PCR TEST. 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 4190377. BHR REVIEW AND RETAIN SAMPLE TESTING CANNOT BE PERFORMED ON BATCH NUMBER UNKNOWN. THE RESULTS WERE ACCEPTABLE FOR 4190377 BHR REVIEW. HOWEVER, THE RETAINED PRODUCT FOR 4190377 RESULTED IN ONE DEVICE WITH A FLU B FALSE POSITIVE USING RV REAGENT D DUE TO A SCRATCH BELOW THE FLU B LINE POSITION. ADDITIONALLY, ANOTHER DEVICE RESULTED IN A TEST INVALID (FLU A POSITIVE AND FLU B POSITIVE) USING THE FLU B NEGATIVE CONTROL SWAB. THERE WERE NO PHOTOGRAPHS RECEIVED. THERE WERE RETURN SAMPLES RECEIVED. THESE RETURN SAMPLES WERE TESTED WITH CONTROL SWABS AND RESULTED IN PASSING RESULTS. THE REPORTED ISSUE WAS CONFIRMED THROUGH RETAIN TESTING. THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. A TREND ANALYSIS FOR FALSE POSITIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. THIS MDR IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW OF RECORDS DATING APRIL 2023-2025, UNDER CAPA 11910483.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, THERE WAS A FALSE POSITIVE RESULT FOR FLU B. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2150682 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B ANTIGEN DETECTION REAGENT KIT QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNKNOWN 00382902560883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown