BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1022431 · Received March 26, 2008

    Report

    Report Number
    1823260-2008-02766
    Event Type
    Malfunction
    Date Received
    March 26, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 26, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT RESULTS FOR CREATININE. INITIAL RESULT GAVE 57.7 UMOL/L; REPEAT GAVE 143.2 UMOL/L. THE SAMPLE WAS REPEATED AGAIN, GIVING RESULTS COMPARABLE TO THE INITIAL RESULT (ACTUAL DATA NOT PROVIDED). NO INFO PROVIDED 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 P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK