BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROL SET FOR THE BD PROBETEC (CT/GC) QX AMPLIFIED DNA ASSAYS

    MDR report key: 11308646 · Received February 10, 2021

    Report

    Report Number
    1119779-2021-00283
    Event Type
    Malfunction
    Date Received
    February 10, 2021
    Date of Event
    December 14, 2020
    Report Date
    January 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LSL
    UDI-DI
    00382904411251
    PMA / PMN Number
    K081825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING SEVERAL INVALID CT/GC POSITIVE CONTROL RESULTS. QUALITY INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS AND FUNCTIONAL ANALYSIS OF RETENTION MATERIALS FROM THE CUSTOMERS REPORTED REAGENT BATCH AS WELL AS COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS OF RETENTION MATERIALS PASSED WITH 100% POSITIVITY FOR CT AND GC. QUALITY WAS UNABLE TO DUPLICATE THE CUSTOMERS REPORTED FAILURE MODE. THERE ARE NO CURRENT COMPLAINT TRENDS AGAINST INVALID CT/GC POSITIVE CONTROL RESULTS ON THE VIPER XTR SYSTEM. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH INVALID CT/GC POSITIVE CONTROL RESULTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS 4 FALSE NEGATIVE RESULTS WERE OBTAINED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203749 CONTROL SET FOR THE BD PROBETEC (CT/GC) QX AMPLIFIED DNA ASSAYS DNA REAGENTS, NEISSERIA LSL BECTON, DICKINSON & CO. (SPARKS) 441125 0247078 00382904411251

    Patients

    Seq Age Sex Outcome Treatment
    1