BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1070454 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05232
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    May 16, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS AN ISSUE WITH DISCREPANT TROPONIN RESULTS WHEN PERFORMING A CORRELATION STUDY. THIRTY-TWO EXAMPLES PROVIDED: SAMPLE 1 INITIAL RESULT <0.01NG/ML, REPEAT 0.015NG/ML. SAMPLE 2 INITIAL RESULT 1.19 NG/ML, REPEAT 0.042 NG/ML. SAMPLE 3 INITIAL RESULT 0.588 NG/ML, REPEAT 0.826 NG/ML. SAMPLE 4 INITIAL RESULT 0.030 NG/ML, REPEAT 0.019 NG/ML. SAMPLE 5 INITIAL RESULT 3.19NG/ML, REPEAT 2.10NG/ML. SAMPLE 6 INITIAL RESULT 0.061NG/ML, REPEAT 0.041NG/ML. SAMPLE 7 INITIAL RESULT 0.022NG/ML, REPEAT <0.010NG/ML. SAMPLE 8 INITIAL RESULT 12.19NG/ML, REPEAT 0.399NG/ML. SAMPLE 9 INITIAL RESULT 4.63NG/ML, REPEAT 03.03NG/ML. SAMPLE 10 INITIAL RESULT 6.41NG/ML, REPEAT 4.93NG/ML. SAMPLE 11 INITIAL RESULT 5.46NG/ML, REPEAT 3.86NG/ML. SAMPLE 12 INITIAL RESULT 6.74NG/ML, REPEAT 5.43NG/ML. SAMPLE 13 INITIAL RESULT 0.039NG/ML, REPEAT 0.023NG/ML. SAMPLE 14 INITIAL RESULT 0.168NG/ML, REPEAT 0.128NG/ML. SAMPLE 15 INITIAL RESULT 0.529NG/ML, REPEAT 0.403NG/ML. SAMPLE 16 INITIAL RESULT 0.107NG/ML, REPEAT 0.074NG/ML. SAMPLE 17 INITIAL RESULT 23.07NG/ML, REPEAT 18.39NG/ML. SAMPLE 18 INITIAL RESULT 11.86NG/ML, REPEAT 9.27NG/ML. SAMPLE 19 INITIAL RESULT 17.17NG/ML, REPEAT 12.96NG/ML. SAMPLE 20 INITIAL RESULT 9.42NG/ML, REPEAT 6.79NG/ML. SAMPLE 21 INITIAL RESULT 8.95NG/ML, REPEAT 6.74NG/ML. SAMPLE 22 INITIAL RESULT 9.12NG/ML, REPEAT 6.73NG/ML. SAMPLE 23 INITIAL RESULT 11.28NG/ML, REPEAT 8.37NG/ML. SAMPLE 24 INITIAL RESULT 8.54NG/ML, REPEAT 6.43NG/ML. SAMPLE 25 INITIAL RESULT 12.35NG/ML, REPEAT 9.39NG/ML. SAMPLE 26 INITIAL RESULT 6.74NG/ML, REPEAT 5.00NG/ML. SAMPLE 27 INITIAL RESULT 9.09NG/ML, REPEAT 7.01NG/ML. SAMPLE 28 INITIAL RESULT 5.03NG/ML, REPEAT 4.05NG/ML. SAMPLE 29 INITIAL RESULT 5.01NG/ML, REPEAT 3.62NG/ML. SAMPLE 30 INITIAL RESULT 4.82NG/ML, REPEAT 3.83NG/ML. SAMPLE 31 INITIAL RESULT 6.34NG/ML, REPEAT 4.70NG/ML. SAMPLE 32 INITIAL RESULT 5.06NG/ML, REPEAT 3.32NG/ML. RESULTS WERE USED FOR CORRELATION STUDY ONLY. FIELD SERVICE REPRESENTATIVE DETERMINED ROOT CAUSE TO BE PARTIALLY BLOCKED SAMPLE PATH AND REPLACED THE SIPPER TUBING, SIPPER PROBE AND MEASURING CELL. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    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