BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1257486 · Received December 4, 2008

    Report

    Report Number
    1823260-2008-08926
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    November 15, 2008
    Report Date
    December 4, 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 PT INITIALLY RECOVERED 0.367 NG/ML AND REPEATED TWICE AS <0.010 NG/ML. THE INITIAL DISCREPANT RESULT WAS REPORTED AND THE PT RECEIVED NO TREATMENT WAS PROVIDED BASED ON THE ERRONEOUS RESULT. IF ADD'L IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    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