BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR SYSTEM FOR RAPID DETECTION OF GROUP A STREP

    MDR report key: 20734136 · Received November 20, 2024

    Report

    Report Number
    3006948883-2024-00083
    Event Type
    Malfunction
    Date Received
    November 20, 2024
    Date of Event
    October 22, 2024
    Report Date
    February 5, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GTY
    UDI-DI
    00382902560401
    PMA / PMN Number
    K122718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES DISCREPANT RESULTS WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL#: 256040), BATCH NUMBER 4023379. THE CUSTOMER REPORTED THAT THEY ARE RECEIVING DISCREPANT RESULTS; THEY ARE VISUALLY SEEING A LINE ON THE PCR CARTRIDGE THEN RECEIVING A NEGATIVE RESULT FROM THE ANALYZER. 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 DISCREPANT RESULTS 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 GROUP A STREP, THE ANALYZER PROVIDED A NEGATIVE STREP RESULT. TWO (2) USERS VISUALLY INSPECTED THE CARTRIDGE AND OBSERVED A FAINT POSITIVE LINE. THE SAME CARTRIDGE WAS RE-RAN AND THE ANALYZER PROVIDED A POSITIVE STREP RESULT. THE NUMBER OF PATIENT SAMPLES INVOLVED WAS NOT CONFIRMED; HOWEVER, AT LEAST ONE (1) PATIENT HAD AN ERRONEOUS RESULT REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VERITOR SYSTEM FOR RAPID DETECTION OF GROUP A STREP, THE ANALYZER PROVIDED A NEGATIVE STREP RESULT. TWO (2) USERS VISUALLY INSPECTED THE CARTRIDGE AND OBSERVED A FAINT POSITIVE LINE. THE SAME CARTRIDGE WAS RE-RAN AND THE ANALYZER PROVIDED A POSITIVE STREP RESULT. THE NUMBER OF PATIENT SAMPLES INVOLVED WAS NOT CONFIRMED; HOWEVER, AT LEAST ONE (1) PATIENT HAD AN ERRONEOUS RESULT REPORTED. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2421280 BD VERITOR SYSTEM FOR RAPID DETECTION OF GROUP A STREP ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4023379 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown