BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 1010

    MDR report key: 1022493 · Received March 31, 2008

    Report

    Report Number
    1823260-2008-02883
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 31, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FOUR PATIENT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. PATIENT 1, INITIAL RESULT GAVE 0.68 NG/ML; REPEAT GAVE < 0.010 NG/ML. PATIENT 2, INITIAL RESULT GAVE 0.04 NG/ML; REPEAT GAVE <0.010 NG/ML. PATIENT 3, INITIAL RESULT GAVE 0.05 NG/ML; REPEAT GAVE < 0.010 NG/ML. PATIENT 4, INITIAL RESULT GAVE 0.04 NG/ML; REPEAT GAVE <0.010 NG/ML. NO INFORMATION PROVIDED, IF RESULT WERE USED TO GUIDE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 1010 IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E1010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK