BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM DIGOXIN III

    MDR report key: 1010007 · Received May 11, 2007

    Report

    Report Number
    2623532-2007-00053
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    February 26, 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
    CA
    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 STATES THAT A CORRELATION STUDY SHOWS HIGHER RESULTS FOR THE AXSYM DIGOXIN III ASSAY COMPARED TO THE AXSYM DIGOXIN II ASSAY ON PT SAMPLES. THE CUSTOMER ALSO STATED THAT SOME SAMPLES WERE TESTED NEAT AND GENERATED RESULTS GREATER THAN 5.12 NG/ML BUT WHEN THE SAMPLES WERE DILUTED, RESULTS WERE LESS THAN 5.12 NG/ML. 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 MEASUREMENT OF DIGOXIN KXT ABBOTT DIAGNOSTICS INTERNATIONAL, LTD. NA 42722Q100

    Patients

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