BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT

    MDR report key: 21809263 · Received April 9, 2025

    Report

    Report Number
    3006948883-2025-00062
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 12, 2025
    Report Date
    May 28, 2025
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GTY
    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

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH ADDITIONAL INFORMATION: D9. DEVICE AVAILABLE FOR EVALUATION: YES. D9. RETURNED TO MANUFACTURER ON: 06-MAY-2025. H3. DEVICE EVAL BY MANUFACTURER: YES. 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 4080985. THE CUSTOMER REPORTED THAT DURING TESTING WITH A PATIENT, THEY INITIALLY GOT A NEGATIVE RESULT ON THE CARTRIDGE WHEN TESTED ON THE ANALYZER, THEY LET THE CARTRIDGE SIT FOR A FEW MINUTES AND SAW A POSITIVE LINE ON THE CARTRIDGE. THEY RE-INSERTED THE CARTRIDGE ON THE ANALYZER AND THE ANALYZER GAVE A POSITIVE RESULT. THEY RE-INSERTED THE SAME CARTRIDGE A THIRD TIME, AND THE ANALYZER GAVE A POSITIVE RESULT AGAIN. THE CUSTOMER DID NOT REPEAT TESTING WITH A NEW CARTRIDGE AND DID NOT RECOLLECT A NEW SAMPLE. 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. THERE WAS A PHOTOGRAPH RECEIVED, SHOWING THE OUTSIDE OF THE KIT BOX AND THE LOT NUMBER INFORMATION. THERE WERE RETURN SAMPLES RECEIVED. FUNCTIONAL TESTING WAS COMPLETED ON THE RETURNED SAMPLES AND THE RESULTS WERE ACCEPTABLE. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A TREND ANALYSIS FOR DISCREPANT RESULT WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. THE CUSTOMER WAS ADVISED THAT IT IS NOT RECOMMENDED TO RE-INSERT A CARTRIDGE ONCE IT HAS BEEN READ AND THAT THE CARTRIDGES ARE NOT MEANT TO BE VISUALLY READ. IF THERE IS A RETEST, IT IS ADVISED TO RECOLLECT THE SAMPLE AND TEST ON A NEW CARTRIDGE. 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 CLIA-WAIVED KIT, ONE (1) PATIENT SAMPLE RESULTED AS GROUP A STREP NEGATIVE FROM THE ANALYZER. AFTER LETTING THE TEST CARTRIDGE SIT FOR A FEW MINUTES, THE CUSTOMER VISUALLY EXAMINED THE TEST CARTRIDGE AND SAW A POSITIVE LINE. THE ANALYZER RESULT WAS QUESTIONED AND THE SAME TEST CARTRIDGE WAS REINSERTED INTO THE ANALYZER AND A GROUP A STREP POSITIVE RESULT WAS OBTAINED. THE CUSTOMER PERFORMED TESTING A THIRD TIME USING THE SAME TEST CARTRIDGE AND THE ANALYZER PROVIDED A GROUP A STREP POSITIVE RESULT. NO SAMPLE RECOLLECTION OR TESTING WITH A NEW CARTRIDGE OCCURRED. THERE WERE 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 CLIA-WAIVED KIT, ONE (1) PATIENT SAMPLE RESULTED AS GROUP A STREP NEGATIVE FROM THE ANALYZER. AFTER LETTING THE TEST CARTRIDGE SIT FOR A FEW MINUTES, THE CUSTOMER VISUALLY EXAMINED THE TEST CARTRIDGE AND SAW A POSITIVE LINE. THE ANALYZER RESULT WAS QUESTIONED AND THE SAME TEST CARTRIDGE WAS REINSERTED INTO THE ANALYZER AND A GROUP A STREP POSITIVE RESULT WAS OBTAINED. THE CUSTOMER PERFORMED TESTING A THIRD TIME USING THE SAME TEST CARTRIDGE AND THE ANALYZER PROVIDED A GROUP A STREP POSITIVE RESULT. NO SAMPLE RECOLLECTION OR TESTING WITH A NEW CARTRIDGE OCCURRED. THERE WERE NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664378 BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF GROUP A STREP CLIA-WAIVED KIT ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 4080985

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown