BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDX/TDXFLX GENTAMICIN REAGENT

    MDR report key: 939739 · Received November 8, 2007

    Report

    Report Number
    2623532-2007-00491
    Event Type
    Malfunction
    Date Received
    November 8, 2007
    Date of Event
    October 25, 2007
    Report Date
    October 25, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
    Product Code
    LCQ
    PMA / PMN Number
    K801084
    Removal / Correction Number
    2623532-11/7/07-008-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ABBOTT AXSYM GENTAMICIN REAGENTS ARE DEMONSTRATING A DECREASE IN THE A CALIBRATOR TO F CALIBRATOR SPAN WHICH MAY RESULT IN ABBOTT GENTAMICIN ASSAY CONTROLS OUT OF RANGE. ABBOTT TDX/TDX FLX GENTAMICIN REAGENTS WERE FOUND TO HAVE A DECREASE IN THE CALIBRATOR A TO F SPAN WHICH MAY PRODUCE ERROR CODE "SPAN LESS THAN MIN" AND ABBOTT GENTAMICIN CONTROLS OUT OF RANGE. AN INVESTIGATION HAS BEEN OPENED TO IDENTIFY THE ROOT CAUSE OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TDX/TDXFLX GENTAMICIN REAGENT FOR THE QUANTITATIVE MEASUREMENT OF GENTAMICIN IN SERUM OR PLASMA LCQ ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA 51187Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR AXSYM GENTAMICIN REAGENT LOTS 53190Q100 AND| 53190Q101| AXSYM GENTAMICIN REAGENT| TDX/TDX FLX & AXSYM ANALYZERS| 4A24