BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM DIGOXIN III

    MDR report key: 1010362 · Received May 11, 2007

    Report

    Report Number
    2623532-2007-00077
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    March 13, 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
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROGRESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AFTER PERFORMING A CORRELATION STUDY BETWEEN THE AXSYM DIGOXIN III AND DIGOXIN II ASSAYS, THE CUSTOMER NOTICED THE TEST RESULTS WERE INACCURATE BETWEEN THE TWO ASSAYS ON PATIENT SAMPLES. THE CUSTOMER GAVE ONE EXAMPLE FOR ONE PATIENT SAMPLE USING THE DIGOXIN III ASSAY WHICH GENERATED A 0.61 NG/ML, AND USING THE DIGOXIN II ASSAY, THE RESULT WAS 1.14 NG/ML THEN REPEATED AT 1.36 NG/ML. THERE WAS NO IMPACT TO PATIENT 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