BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1198688 · Received October 14, 2008

    Report

    Report Number
    1823260-2008-07599
    Event Type
    Malfunction
    Date Received
    October 14, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 14, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER REPORTS ERRONEOUS TNT AND CKMB RESULTS FOR ONE PATIENT SAMPLE. INITIAL RESULTS: TNT 0.010 NG/ML, CKMB 7.11NG/ML. REPEAT RESULTS: TNT 0.112 NG/ML, CKMB 3.03 NG/ML. THIRD TNT REPEAT 0.011 NG/ML. REPEAT TESTING ON ANOTHER ANALYZER: TNT 0.013 NG/ML, CKMB 2.94 NG/ML. INITIAL CKMB AND REPEAT TNT RESULTS WERE REPORTED. THE USER IS UNAWARE OF ANY ADVERSE EFFECTS OR TREATMENT OF THE PATIENT BASED ON THE RESULTS. THE USER ALERTED THE INPATIENT UNIT AS SOON AS THE ERRONEOUS RESULT WAS REALIZED. THE FIELD SERVICE REPRESENTATIVE COULD NOT DETERMINE A CAUSE, BUT NOTED THAT STIRRER SPEED WAS HIGH. STIRRER SPEED AND VOLTAGE WERE ADJUSTED. 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. 2010 RACK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR