BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM DIGOXIN III

    MDR report key: 1010047 · Received May 11, 2007

    Report

    Report Number
    2623532-2007-00163
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    January 12, 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
    FR
    Reporter Occupation
    UNKNOWN

    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 WHILE PERFORMING A CORRELATION STUDY BETWEEN THE AXSYM DIGOXIN II ASSAY VS. THE AXSYM DIGOXIN III ASSAY, THEY NOTED THAT PTS SAMPLES RESULTS GENERATED ON THE AXSYM DIGOXIN III WERE HIGHER COMPARED TO AXSYM DIGOXIN II. FOR EXAMPLE, A PT SAMPLE GENERATED A RESULT OF 1.08 NG/ML USING THE AXSYM DIGOXIN III WHICH IS HIGHER THAN THE RESULT OF 0.91 NG/ML USING THE AXSYM DIGOXIN II. THE CUSTOMER ALSO STATES, THAT THEY ARE SOMETIMES GETTING ERROR CODE 1118 (INVALID TEST RESULT, INTERCEPT TOO LOW) AND ERROR CODE 1062 (INVALID TEST RESULT, READ PRECISION) WHEN RUNNING A PT SAMPLE ON THE AXSYM DIGOXIN III. THERE WAS NO IMPACT TO PTS 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