BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM DIGOXIN III

    MDR report key: 1010271 · Received May 11, 2007

    Report

    Report Number
    2623532-2007-00142
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    March 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
    UK
    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 COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT AFTER TESTING THE AXSYM DIGOXIN III ASSAY, ERROR CODE# 1118 (INVALID TEST RESULT, INTERCEPT TOO LOW) WAS GENERATED ON A PT SAMPLE. THE CUSTOMER DILUTED THE SAMPLE AND RECEIVED A RESULT. THE CUSTOMER ALSO STATED THAT A RESULT WAS GENERATED ON THAT SAMPLE WHEN TESTED ON THE DIGOXIN II ASSAY. 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