BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1236845 · Received October 29, 2008

    Report

    Report Number
    1823260-2008-08006
    Event Type
    Malfunction
    Date Received
    October 29, 2008
    Date of Event
    October 19, 2008
    Report Date
    October 29, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT TROPONIN T RESULTS FOR ONE PT SAMPLE. THE INITIAL BASELINE RESULT WAS 0.108 NG/ML. SAME SAMPLE WAS REPEATED NEXT DAY WHICH RESULTED AT <0.010 NG/ML. THE INITIAL RESULT WAS REPORTED AND USER DID NOT THINK PT WAS ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A CAUSE AND COULD NOT DUPLICATE THE PROBLEM. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER - JJE MMI HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK