BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 18194970 · Received November 22, 2023

    Report

    Report Number
    3014704491-2023-00752
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 22, 2023
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. RETURNED TO MANUFACTURER ON 20-NOV-2023. H6: INVESTIGATION SUMMARY: THIS STATEMENT IS TO SUMMARIZE THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVE RESULTS WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL # 256040), BATCH NUMBERS 3040598. PER CUSTOMER, THEY WERE SEEING AN INCREASE IN POSITIVE STREP A RESULTS FROM PATIENTS THAT DO NOT PRESENT TYPICAL CLINICAL SYMPTOMS. CUSTOMER WAS SENDING SWABS FOR CULTURE, AND THEY CAME BACK AS NEGATIVE. THEY USED OTHER LOT NUMBERS AND RECEIVED ACCEPTABLE RESULTS. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE ALL FALSE POSITIVE 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 IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED ON THE DEVICES RETURNED BY THE CUSTOMER, AND THE ASSAY HAD TYPICAL INTENDED RESULTS. NO RELEVANT ISSUES WERE IDENTIFIED. THE CUSTOMER ALSO PROVIDED THE PHOTOGRAPH OF VERITOR ANALYZER; HOWEVER, THE REPORTED ISSUE COULD NOT BE IDENTIFIED BASED ON THE PHOTOGRAPHS. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED BASED ON THE INVESTIGATION. THE ROOT CAUSE COULD NOT BE DETERMINED. CURRENTLY NO ADVERSE TREND FOR FALSE POSITIVE WAS IDENTIFIED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT GRP A STREP 30 TEST VERITOR FALSE POSITIVE RESULTS WERE OBTAINED. CUSTOMER IS SENDING SWABS FOR CULTURE AND THE CULTURES CAME BACK NEGATIVE. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING KIT GRP A STREP 30 TEST VERITOR FALSE POSITIVE RESULTS WERE OBTAINED. CUSTOMER IS SENDING SWABS FOR CULTURE AND THE CULTURES CAME BACK NEGATIVE. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2028338 KIT GRP A STREP 30 TEST VERITOR ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 3040598 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown