BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD RAPID DETECTION OF SARS-COV-2 VERITOR¿

    MDR report key: 18575679 · Received January 24, 2024

    Report

    Report Number
    3006948883-2024-00008
    Event Type
    Malfunction
    Date Received
    January 24, 2024
    Date of Event
    January 8, 2024
    Report Date
    June 18, 2024
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    QKP
    UDI-DI
    00382902560821
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G.5: PMA/510(K)#: EUA: (B)(4). H.3: 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

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES 2 INSTANCES OF FALSE NEGATIVE WHEN USING BD VERITOR¿ SARS-COV-2 KIT (MATERIAL#: 256082), BATCH NUMBER 3250429. THE CUSTOMER REPORTED THAT THEY RECEIVED TWO FALSE NEGATIVES WITH 2 DIFFERENT PATIENT SAMPLES. 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 OR SAMPLES WERE RECEIVED; THEREFORE, RETURN SAMPLE ANALYSIS COULD NOT BE PERFORMED. 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. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 0

    REPORT 2 OF 2. IT WAS REPORTED WHEN USING THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿, FALSE NEGATIVE COVID RESULTS WERE OBTAINED WITH TWO (2) DIFFERENT PATIENTS. REPEAT CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT RAPID ASSAY (CATALOG #256088 TRIPLEX FLU A/B & COVID) AND COVID POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD RAPID DETECTION OF SARS-COV-2 VERITOR¿, FALSE NEGATIVE COVID RESULTS WERE OBTAINED WITH TWO (2) DIFFERENT PATIENTS. REPEAT CONFIRMATORY TESTING WAS PERFORMED USING A DIFFERENT RAPID ASSAY (CATALOG #256088 TRIPLEX FLU A/B & COVID) AND COVID POSITIVE RESULTS WERE OBTAINED. THERE WAS NO REPORT OF PATIENT IMPACT. EUA(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478267 BD RAPID DETECTION OF SARS-COV-2 VERITOR¿ CORONAVIRUS ANTIGEN DETECTION SYSTEM QKP BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3250429 00382902560821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown