BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1053004 · Received May 27, 2008

    Report

    Report Number
    1823260-2008-04302
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 2, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    TWO PATIENTS WITH DISCREPANT CREATININE RESULTS. PATIENT 1 INITIAL RESULT 4.7 MG/DL, REPEAT 1.0 MG/DL. INITIAL RESULT REPORTED, PATIENT NOT ADVERSELY AFFECTED. PATIENT 2 INITIAL RESULT 1.4 MG/DL, REPEAT 0.5 MG/DL. INITIAL RESULT NOT REPORTED. FIELD SERVICE REP FOUND ROOT CAUSE TO BE BENT REAGENT PROBE WHICH WAS ADJUSTED. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK