BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2

    MDR report key: 22951935 · Received September 3, 2025

    Report

    Report Number
    3006948883-2025-00646
    Event Type
    Malfunction
    Date Received
    September 3, 2025
    Date of Event
    July 4, 2024
    Report Date
    July 10, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    UDI-DI
    00382902560821
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.4. PMA/510(K)#: EUA# (B)(4). INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING BD VERITOR¿ SARS-COV-2 KIT (MATERIAL#: 256082), BATCH NUMBER 4081455. THE CUSTOMER REPORTED THAT THEY SAW THE CONTROL LINE AND THE TEST LINE ON THE CARTRIDGE BUT RECEIVED A NEGATIVE RESULT FROM ANALYZER WHEN THEY TESTED A PATIENT WITH SYMPTOMS. 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 PHOTOS WERE RECEIVED. RETURN SAMPLES WERE RECEIVED ON THE BATCH NUMBER PROVIDED. THEY WERE TESTED AND THE RESULTS WERE ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE NEGATIVE 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 (B)(6) 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, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256037 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF SARS-COV-2 CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4081455 00382902560821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown