BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 22892491 · Received August 26, 2025

    Report

    Report Number
    3006948883-2025-00537
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    June 6, 2023
    Report Date
    June 30, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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 3032098. IT WAS REPORTED BY THE CUSTOMER THAT DESPITE SEEING TWO RED LINES, THEY RECEIVED NEGATIVE RESULT WHEN INSERTING THE CARTRIDGE IN THE ANALYZER. BD REPRESENTATIVE INFORMED THE CUSTOMER THAT THE RED LINES ARE NOT WHAT THE READER USES AND THAT THEY AREN'T A REFLECTION OF THE RESULTS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING 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. BASED ON THE AVAILABLE INFORMATION IT WAS UNDERSTOOD THAT THE CUSTOMER HAD PERFORMED THE TEST AND RECEIVED A VALID RESULT (POSITIVE) THEN THEY RE-INSERTED THE SAME CARTRIDGE IN THE INSTRUMENT, AND IT GAVE A NEGATIVE RESULT. BD REPRESENTATIVE ADVISED THE CUSTOMER THAT THIS TEST NEVER BEEN DESIGNED TO BE READ VISUALLY; THE TEST RESULTS NEED TO BE ANALYZED THROUGH THE BD ANALYZER, ALSO THE SAME TEST CARTRIDGE SHOULD NOT BE REINSERTED. THIS COMPLAINT WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. NO CORRECTIVE ACTIONS WERE 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 THE KIT GRP A STREP 30 TEST VERITOR, THERE WAS A FALSE NEGATIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1866256 KIT GRP A STREP 30 TEST VERITOR ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3032098 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown