BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23870659 · Received December 22, 2025

    Report

    Report Number
    3006948883-2025-00957
    Event Type
    Malfunction
    Date Received
    December 22, 2025
    Date of Event
    November 25, 2025
    Report Date
    February 12, 2026
    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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 3006948883-2025-00957 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE, THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    THE INFORMATION FOR THE 510K IS AS FOLLOWS: G4. PMA/510(K)#: EUA (B)(4). INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULT WHEN USING BD VERITOR¿ SARS-COV-2 AND FLU A+B ASSAY (MATERIAL#: 256088), BATCH NUMBER 5181525. THE CUSTOMER REPORTED THAT THEY OBSERVED FOUR LINES ON TWO DIFFERENT TEST CARTRIDGES. THEY CONFIRMED THAT THEY DID RE-INSERT THE CARTRIDGE IN THE ANALYZER WITH THE KNOWLEDGE THAT THE CARTRIDGE SHOULD NOT BE RE-INSERTED IF IT HAS ALREADY BEEN TESTED AND IS OUTSIDE THE READING WINDOW. ADDITIONALLY, THEY CONFIRMED THAT THEY RAN THE SAME SWAB TWICE, RECEIVING THE SAME RESULTS. THEY RECOLLECTED A NEW SAMPLE, AND RECEIVED A VALID RESULT. 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. THE RESULTS WERE ACCEPTABLE, AND NO RELEVANT ISSUES WERE FOUND. NO SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. HOWEVER, A PHOTOGRAPH WAS RETURNED SHOWING TWO TEST CARTRIDGES WITH 4 LINES: A CONTROL LINE, B LINE, A LINE, AND THE NEGATIVE CONTROL (NC) LINE. THE NC LINE FUNCTIONS TO BIND WITH INTERFERING ANTIBODIES THAT MAY BE PRESENT IN A SAMPLE AND WILL REDUCE THE CHANCES OF THESE INTERFERING BODIES TO BIND TO THE OTHER TEST LINES. SINCE THE POSITIVE CONTROL (C) LINE IS VISIBLE IN THE PHOTO RECEIVED, THE TESTS ARE VALID AND THE ASSAY IS THEREFORE FUNCTIONING AS EXPECTED. HOWEVER, THE ISSUE REPORTED CANNOT BE CONFIRMED THROUGH THIS IMAGE ALONE, WITHOUT ANALYZER DATA. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B, FOUR LINES WERE VISUALLY OBSERVED ON TWO (2) DIFFERENT TEST CARTRIDGES AFTER USING THE SAME SWAB FROM THE SAME PATIENT. THE INITIAL RESULTS PROVIDED FROM THE VERITOR ANALYZER WERE NOT ABLE TO BE PROVIDED. THE CUSTOMER WHO DID NOT PERFORM THE INITIAL TESTING DID RE-INSERT THE CARTRIDGE AFTER IT HAD BEEN TESTED WITH THE KNOWLEDGE THAT THIS IS OFF-LABEL USE. IT WAS NOTED THE PATIENT SAMPLE WAS RECOLLECTED AND VALID RESULTS WERE OBTAINED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED. NO FURTHER INFORMATION WAS ABLE TO BE PROVIDED FROM THE CUSTOMER. EUA(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2209868 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 & FLU A+B ANTIGEN DETECTION REAGENT KIT QMN BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 5181525 00382902560883

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown