BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1003488 · Received February 21, 2008

    Report

    Report Number
    1823260-2008-01753
    Event Type
    Malfunction
    Date Received
    February 21, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 21, 2008
    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

    ONE PT SAMPLE WITH DISCREPANT PTH RESULTS. INITIAL RESULT GAVE 5000 PG/ML. SAME SAMPLE REPEATED USING DIFFERENT METHOD GAVE RESULT OF 227 PG/ML. NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER -JJE JJE ROCHE DIAGNOSTICS E MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR TAHOR| KAYEXALATE| ARANESP| FOSRENOL| DUPHALAC| NEXIUM| EMLAPATCH