BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1191553 · Received September 26, 2008

    Report

    Report Number
    1823260-2008-07216
    Event Type
    Malfunction
    Date Received
    September 26, 2008
    Date of Event
    September 19, 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
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS FOR TROPONIN T. FOUR SAMPLES ARE INVOLVED SAMPLE 1 INITIAL RESULT 0.015 NG/ML, REPEAT 0.018 NG/ML AND IN 2008 GAVE 0.012 NG/ML. SAMPLE 2 INITIAL RESULT 0.020 NG/ML, REPEATED THE SAME DAY GAVE 0.013 NG/ML. SAMPLE 3 INITIAL RESULT 0.016 NG/ML, REPEATED SAME DAY GAVE <0.010 NG/ML. SAMPLE 4 INITIAL RESULT 0.020 NG/L, REPEATED ON THE SAME DAY GAVE 0.016 NG/ML. USER STATES AT RESULT OF <0.03 NG/ML WAS REPORTED SINCE ORIGINAL AND REPEAT RESULTS ARE <0.03 NG/ML AND SHE DID NOT NEED TO CORRECT ANY RESULTS. THE FIELD SERVICE REPRESENTATIVE WAS NOT ABLE TO FIND A CAUSE AS USER REFUSED SERVICE VISIT.

    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 UNK