BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM DIGOXIN III

    MDR report key: 1010006 · Received May 11, 2007

    Report

    Report Number
    2623532-2007-00052
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    February 5, 2007
    Report Date
    April 11, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS INTERNATIONAL, LTD.
    Product Code
    KXT
    PMA / PMN Number
    K061249
    Removal / Correction Number
    2623532-4/10/07-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    THE CUSTOMER STATED THAT AFTER RUNNING THE AXSYM DIGOXIN III ASSAY, PT SAMPLES HAVE BEEN GENERATING AN ERROR CODE #1118 (INVALID TEST RESULT, INTERCEPT TOO LOW). THE CUSTOMER STATED THAT AFTER RE-CENTRIFUGING THE PT SAMPLES, THE SAME ERROR CODE WAS GENERATED, A RESULT WAS RECEIVED ONLY AFTER DILUTING THE SAMPLES. THERE WAS NO IMPACT TO PT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM DIGOXIN III MEIA FOR THE MEASUREMENT OF DIGOXIN KXT ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA 42722Q100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI AXSYM ANALYZER LIST #7A83-01