BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT GRP A STREP 30 TEST VERITOR

    MDR report key: 18751806 · Received February 21, 2024

    Report

    Report Number
    3006948883-2024-00023
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    December 19, 2023
    Report Date
    June 25, 2024
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GTY
    UDI-DI
    00382902560401
    PMA / PMN Number
    K122718
    Adverse Event
    Yes
    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

    THE FOLLOWING FIELDS WERE UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION: B1. TYPE OF REPORT: ADVERSE EVENT AND PRODUCT PROBLEM. B2. OTHER: CHANGE IN TREATMENT. B5. IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR, IT GAVE A FALSE POSITIVE RESULT. PATIENT WAS TREATED WITH ANTIBIOTICS. REPORT 2 OF 2. H1. TYPE OF REPORTABLE EVENT: SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    H3. 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

    H.6. INVESTIGATION SUMMARY: THIS STATEMENT SUMMARIZES THE INVESTIGATION RESULTS REGARDING A COMPLAINT THAT ALLEGES FALSE POSITIVES WHEN USING KIT GRP A STREP 30 TEST VERITOR (MATERIAL#: 256040), BATCH NUMBER 3150180. THE CUSTOMER REPORTED THAT THEY WERE RECEIVING A FALSE POSITIVE RESULT WITH PATIENT SAMPLE USING THE VERITOR ANALYZER. THEY THEN SUBMITTED THE SAMPLES FOR CULTURE AND RECEIVED A NEGATIVE RESULT. 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 FALSE POSITIVE 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 THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR, IT GAVE A FALSE POSITIVE RESULT. PATIENT WAS TREATED WITH ANTIBIOTICS. REPORT 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR, IT GAVE A FALSE POSITIVE RESULT. THERE WAS NO REPORT OF PATIENT IMPACT. REPORT 2 OF 2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE KIT GRP A STREP 30 TEST VERITOR, IT GAVE A FALSE POSITIVE RESULT. PATIENT WAS TREATED WITH ANTIBIOTICS. REPORT 2 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483535 KIT GRP A STREP 30 TEST VERITOR ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP. GTY BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 3150180 00382902560401

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other