BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TDX/TDXFLX GENTAMICIN REAGENT

    MDR report key: 973840 · Received January 4, 2008

    Report

    Report Number
    2623532-2008-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2008
    Date of Event
    December 10, 2007
    Report Date
    December 19, 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
    SP
    Reporter Occupation
    PHYSICIAN

    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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED ABBOTT TO REPORT A CALIBRATION ERROR MESSAGE "SPAN LESS THAN MIN" FOR THE TDX/TDX FLX GENTAMICIN ASSAY ON THE TDX ANALYZER. THE CUSTOMER WAS SENT A NEW LOT OF TDX GENTAMICIN REAGENT. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED BY THE CUSTOMER.

    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 TDX FPIA ANALYZER