BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK RET

    MDR report key: 976748 · Received January 8, 2008

    Report

    Report Number
    1823260-2008-00301
    Event Type
    Malfunction
    Date Received
    January 8, 2008
    Date of Event
    December 14, 2007
    Report Date
    January 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH DISCREPANT TSH RESULTS. SAME SAMPLES USED FOR REPEAT TESTING ON SAME ANALYZER. PT 1, INITIAL TSH RESULT FROM 2007, GAVE 0.04 UIU/ML; REPEAT GAVE 2.69 UIU/ML. PT 2, INITIAL TSH RESULT FROM 2007, GAVE 0.04 UIU/ML; REPEAT GAVE 1.41 UIU/ML. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE SAMPLE CONTAINERS USED BY CUSTOMER, WORN SAMPLE DISK AND PROBE OUT OF ADJUSTMENT. PERFORMED ADJUSTMENT TO PROBE, REPLACED WORN SAMPLE DISK AND DISCUSSED WITH CUSTOMER THE USE OF UNAPPROVED NESTING CUPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECSYS 2010 DISK RET IMMUNOCHEMISTRY ANALYZER-JJE JJE ROCHE DIAGNOSTICS E2010 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK