BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 DISK

    MDR report key: 1780191 · Received September 21, 2007

    Report

    Report Number
    1823260-2007-08263
    Event Type
    Malfunction
    Date Received
    September 21, 2007
    Date of Event
    September 18, 2007
    Report Date
    September 21, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER TESTED SAMPLE BARCODED WITH IDENTIFICATION NUMBER OF (B)(4) FOR TSH AND GAVE RESULT OF 2.50 UIU/ML. A DIFFERENT SAMPLE FROM A DIFFERENT PT, ID NUMBER (B)(4), WAS PLACED IN THE SAME RUN IN A DIFFERENT POSITION ON THE INSTRUMENT. THE INSTRUMENT READ THE BARCODE FOR THIS SAMPLE AS (B)(4), INSTEAD OF (B)(4) THE SAMPLE WAS TESTED FOR TSH AND GAVE RESULT OF 1.67 UIU/ML. THE SAMPLES WERE BOTH THEN REPEATED, THIS TIME READING THE CORRECT IDENTIFICATION NUMBER FOR BOTH PTS. THE REPEAT TSH RESULT FOR SAMPLE (B)(4) WAS 2.05 UIU/ML. IF ADDITIONAL INFO IS REC'D, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA