BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18924754 · Received March 18, 2024

    Report

    Report Number
    1119779-2024-00214
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Date of Event
    January 26, 2024
    Report Date
    April 22, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    LSL
    UDI-DI
    00382904411251
    PMA / PMN Number
    K081825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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: BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED AN INVESTIGATION INTO MISSING BARCODE/LABEL INFORMATION ON A CT/GC QX CONTROL TUBE (CATALOG # 441125, BATCH # 2262861). BD INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS, REVIEW OF RETENTION MATERIALS FROM THE CUSTOMERS REPORTED REAGENT BATCH, REVIEW OF CUSTOMER RETURNED PHOTOGRAPHIC EVIDENCE AND COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. RETENTION MATERIALS FROM THE CUSTOMERS REPORTED REAGENT BATCH REVEALED PROPERLY LABELED TUBES. HOWEVER, REVIEW OF THE CUSTOMERS RETURNED PHOTOGRAPHIC EVIDENCE REVEALED MISSING BARCODE/LABEL INFORMATION ON A CT/GC QX CONTROL TUBE, THUS CONFIRMING THE CUSTOMERS REPORT. NO NEW COMPLAINT TRENDS ASSOCIATED WITH MISSING BARCODE/LABEL INFORMATION ON A CT/GC QX CONTROL TUBE OCCURRED DURING (B)(6) 2024. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH MISSING BARCODE/LABEL INFORMATION ON A CT/GC QX CONTROL TUBE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, A CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS HAD A LABEL WITH MISSING BARCODE, LOT NUMBER, AND EXPIRATION DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE, A CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS HAD A LABEL WITH MISSING BARCODE, LOT NUMBER, AND EXPIRATION DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553444 CONTROL SET FOR THE BD PROBETEC¿ (CT/GC) QX AMPLIFIED DNA ASSAYS DNA REAGENTS, NEISSERIA LSL BECTON, DICKINSON & CO. (SPARKS) 2262861 00382904411251

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown