BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV

    MDR report key: 12530516 · Received September 24, 2021

    Report

    Report Number
    3006948883-2021-00947
    Event Type
    Malfunction
    Date Received
    September 24, 2021
    Date of Event
    August 30, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    GQG
    UDI-DI
    00382902560425
    PMA / PMN Number
    K133140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 THE COMPLAINT THAT ALLEGES GETTING DISCREPANT RESULTS (POSITIVE RESULT IS NEGATIVE WHEN REPEATED) WHEN USING KIT RSV 30 TEST HOSPITAL VERITOR (MATERIAL # 256042), BATCH NUMBER 9227487. BD QUALITY PERFORMS A SYSTEMATIC APPROACH TO INVESTIGATE DISCREPANT RESULTS COMPLAINTS. THIS APPROACH INVOLVES REVIEW OF MANUFACTURING BATCH HISTORY RECORDS, TESTING OF RETENTION SAMPLES, AND TESTING OF CUSTOMER RETURNED SAMPLES, IF APPLICABLE. AN INVESTIGATION AND TESTING WERE PERFORMED ON THE BATCH NUMBER PROVIDED AND NO RELEVANT ISSUE WAS FOUND. THE COMPLAINT WAS UNABLE TO BE CONFIRMED VIA THE RETAIN SAMPLES. THE ROOT CAUSE COULD NOT BE IDENTIFIED. A TREND ANALYSIS DISCREPANT RESULTS WAS CONDUCTED, NO ADVERSE TREND WAS IDENTIFIED. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS. THERE WERE NO CORRECTIVE ACTIONS TAKEN AT THIS TIME. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV 3 FALSE POSITIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCREPANCY ON RESULTS. CUSTOMER IS GETTING DISCREPANCY RESULTS ON RSV 256042 LOT: 9227487 EXP: 3/6/2022"

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV (B)(6)RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCREPANCY ON RESULTS. CUSTOMER IS GETTING DISCREPANCY RESULTS ON RSV 256042 LOT: 9227487 EXP: 3/6/2022".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1427305 BD VERITOR SYSTEM FOR RAPID DETECTION OF RSV ANTIGEN, CF , RESPIRATORY SYNCYTIAL VIRUS GQG BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 256042 9227487 00382902560425

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown