BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1191554 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07217
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    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 A HIGH RESULT FOR TROPONIN T FOR ONE PATIENT THAT WAS QUESTIONED BY THE PHYSICIAN. INITIAL RESULT 0.183 NG/ML, WHEN REPEATED GAVE <0.01 NG/ML TWICE. A CORRECTED REPORT WAS POSTED AND PHYSICIAN WAS NOTIFIED. NO INFORMATION WAS PROVIDED TO DETERMINE IF PATIENT WAS ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DUPLICATE THE ISSUE BUT CHECKED THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 DISK IMMUNOCHEMISTRY ANALYZER - JJE MMI ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR