BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1082535 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05689
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER REPORTS ONE PATIENT WITH DISCREPANT CREATININE RESULTS. INITIAL RESULT 2.9 MG/DL, REPEATED THREE TIMES GAVE RESULT OF 3.8 MG/DL EACH TIME. INITIAL RESULT WAS REPORTED, PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE ROOT CAUSE, BUT NOTED HE REPLACED SV VALVES ON ALL SYRINGE UNITS, HEAT CUT FILTERS, R1 AND R2 STIRRER PADDLES, HC RINSE UNIT NOZZLES AND R1 AND R2 PROBES. PERFORMANCE TESTS WERE PERFORMED AND WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK