BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1336393 · Received December 15, 2008

    Report

    Report Number
    1823260-2008-09199
    Event Type
    Malfunction
    Date Received
    December 15, 2008
    Date of Event
    November 28, 2008
    Report Date
    December 15, 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
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED A DISCREPANT TROPONIN T RESULT FOR ONE PT SAMPLE. THE SAMPLE INITIALLY RECOVERED 0.116 NG/ML AND REPEATED TWICE AS 0.056 NG/ML AND 0.052 NG/ML. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND RECOVERED 0.057 NG/ML. THE RESULT OF 0.057 NG/ML WAS REPORTED. THE FIELD SERVICE REPRESENTATIVE COULD NOT DUPLICATE THE ISSUE. HE ADJUSTED THE SIPPER RINSE MECHANISM AND CHECKED THE SAMPLE PIPETTE. 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 99 YR