BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1083166 · Received July 24, 2008

    Report

    Report Number
    1823260-2008-05756
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 24, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING LOW RESULTS FOR MULTIPLE PATIENT SAMPLES FOR MULTIPLE ASSAYS. EIGHT EXAMPLES PROVIDED. SAMPLE 1 INITIAL TSH RESULT <0.01 MIU/ML, REPEAT <0.005 MIU/ML. SAMPLE 2 INITIAL TSH RESULT 1.30 MIU/ML, REPEAT 2.29 MIU/ML. SAMPLE 3 INITIAL TSH RESULT 2.49 MIU/ML, REPEAT 6.17 MIU/ML. SAMPLE 4 INITIAL FT4 RESULT 4.87 NG/DL, REPEAT 1.88 NG/DL. SAMPLE 5 INITIAL CKMB RESULT 1.91 NG/ML, REPEAT 3.31 NG/ML. SAMPLE 6 INITIAL TSH 25.28 MIU/ML, REPEAT 38.91 MIU/ML. SAMPLE 7 INITIAL TSH 1.77 MIU/ML, REPEAT 2.80 MIU/ML. SAMPLE 8 INITIAL TSH 0.63 MIU/ML, REPEAT 1.90 MIU/ML. INITIAL RESULTS WERE REPORTED, PATIENTS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED ISSUE TO BE THE REAGENT MIXER WAS NOT MIXING AND REPLACED THE MIXER MOTOR BELT. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK