BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK

    MDR report key: 1011353 · Received March 11, 2008

    Report

    Report Number
    1823260-2008-02286
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 14, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    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

    FOUR PATIENT SAMPLES SHOWING DISCREPANT TROPONIN T STAT RESULTS. PATIENT 1, INITIAL RESULT 0.240 NG/ML; REPEATED TWICE GAVE 0.069 AND 0.075 NG/ML. THE INITIAL RESULTS ALL WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 2

    FOUR PATIENT SAMPLES SHOWING DISCREPANT TROPONIN T STAT RESULTS. PATIENT 2, INITIAL RESULT 0.135 NG/ML; REPEATED TWICE GAVE <0.010 NG/ML BOTH TIMES. THE INITIAL RESULTS ALL WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 3

    FOUR PATIENT SAMPLES SHOWING DISCREPANT TROPONIN T STAT RESULTS. PATIENT 3, INITIAL RESULT 0.099 NG/ML; REPEAT GAVE 0.035 NG/ML. THE INITIAL RESULTS ALL WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Description of Event or Problem · 4

    FOUR PATIENT SAMPLES SHOWING DISCREPANT TROPONIN T STAT RESULTS. PATIENT 4, INITIAL RESULT 0.060 NG/ML; REPEAT GAVE <0.010 NG/ML. THE INITIAL RESULTS ALL WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E 411

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR
    2 69 YR
    3 90 YR
    4 72 YR