BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1296311 · Received December 8, 2008

    Report

    Report Number
    1823260-2008-08996
    Event Type
    Malfunction
    Date Received
    December 8, 2008
    Date of Event
    November 19, 2008
    Report Date
    December 8, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS TROPONIN T RESULTS FOR ONE PT SAMPLE. THE SAMPLE INITIALLY RECOVERED 0.059 NG/ML AND REPEATED SIX TIMES AS <0.010 NG/ML, 0.082 NG/ML, 0.064 NG/ML, <0.010 NG/ML, <0.010 NG/ML, AND <0.010 NG/ML. THE ERRONEOUS RESULTS WERE NOT REPORTED. USER STATED THE ISSUES HAVE BEEN GOING ON FOR THE LEAST YEAR; HOWEVER, NO ADD'L DATA OR INFO WAS PROVIDED REGARDING PRIOR EVENTS IN THIS COMPLAINT. THE FIELD SERVICE REP COULD NOT DETERMINE A CAUSE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 RACK IMMUNOCHEMISTRY ANALYZER - JJE MMI HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR