BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS 2010 RACK

    MDR report key: 1762638 · Received July 12, 2007

    Report

    Report Number
    1823260-2007-05917
    Event Type
    Malfunction
    Date Received
    July 12, 2007
    Date of Event
    June 1, 2007
    Report Date
    July 9, 2007
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT SAMPLE WITH DISCREPANT FREE T4 RESULTS. INITIAL RESULT 29 PMOL/L. SAME SAMPLE REPEATED USING DIFFERENT METHOD GAVE RESULT OF 15.9 PMOL/L. PREVIOUSLY PATIENT HAD GIVEN THE FOLLOWING FREE T4 RESULTS USING THE INITIAL METHOD: (B)(6) 2007: 27 PMOL/L; (B)(6) 2007: 31 PMOL/L; (B)(6) 2007: 28 PMOL/L. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NEBILET - UNK 5 MG X1| AMLODIPINE - UNK 10 MG X1| RENITEC - UNK 20 MG X2