BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1054543 · Received May 29, 2008

    Report

    Report Number
    1823260-2008-04375
    Event Type
    Malfunction
    Date Received
    May 29, 2008
    Date of Event
    June 20, 2007
    Report Date
    May 29, 2008
    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

    SEVEN PATIENTS WITH DISCREPANT BETA HCG RESULTS, PATIENT 1, 2007, INITIAL RESULT 7.35 MIU/ML, REPEAT 1223 MIU/ML. PATIENT 2, 2007, INITIAL RESULT 0.1 MIU/ML, REPEAT 576 MIU/ML. PATIENT 3, 2007, INITIAL RESULT 74.9 MIU/ML, REPEAT 25036 MIU/ML (DILUTED 1/100). PATIENT 4, 2008, INITIAL RESULT 2.07 MIU/ML, REPEAT 307.9 MIU/ML. PT 5, 2008, INITIAL RESULT 32.1 MIU/ML, REPEAT 7523 MIU/ML. PATIENT 6, 2008, INITIAL RESULT 22.43 MIU/ML, REPEAT 5197 MIU/ML. PT 7, 2008, INITIAL RESULT 56.03 MIU/ML, REPEAT 16809 MIU/ML (DILUTED 1/100). NO INFO PROVIDED TO DETERMINE IF RESULTS WERE USED TO GUIDE THERAPY. IF ADD'L 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 UNK