BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 22975202 · Received September 5, 2025

    Report

    Report Number
    3006948883-2025-00579
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Date of Event
    December 11, 2023
    Report Date
    July 10, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    GTY
    UDI-DI
    00382902560401
    PMA / PMN Number
    K122718
    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

    INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE NEGATIVE WHEN USING BD VERITOR¿ STREP A KIT (MATERIAL#: 256040), BATCH NUMBER 3243664. THE CUSTOMER REPORTED THAT THEY HAD SEVERAL RESULTS FROM THE VERITOR PRODUCT THAT WERE NEGATIVE, BUT THE CULTURES CAME BACK WITH POSITIVE RESULTS. 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 HAVE BEEN RECEIVED AND WERE TESTED; THERE WERE NO RELEVANT ISSUES FOUND AND THE SAMPLES PASSED. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR FALSE NEGATIVE WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THE CUSTOMER WAS INFORMED THAT THE CULTURE IS MORE SENSITIVE AND REITERATED THE STATEMENT IN THE PRODUCT INSERT THAT STATES THIS TEST SHOULD BE USED IN CONJUNCTION WITH CULTURE. THE CUSTOMER WAS ADVISED THAT THEY ARE WELCOME TO CONTINUE USING THE LOT AND SENDING SPECIMENS FOR CULTURE SINCE QC AND THE VERIFICATION CARTRIDGE HAVE PASSED. 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. 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 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
    305401 KIT GRP A STREP 30 TEST VERITOR ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 3243664 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown