BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1070458 · Received July 7, 2008

    Report

    Report Number
    1823260-2008-05230
    Event Type
    Malfunction
    Date Received
    July 7, 2008
    Date of Event
    June 13, 2008
    Report Date
    July 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONCE PATIENT WITH DISCREPANT ALBUMIN AND BICARBONATE RESULTS. INITIAL ALBUMIN RESULT 6.1 G/L, REPEAT 4.4 G/L. INITIAL BICARBONATE RESULT 44 MEQ/L, REPEAT 26 MEQ/L. INITIAL RESULTS WERE NOT REPORTED. FIELD SERVICE REPRESENTATIVE DETERMINED ROOT CAUSE TO BE WORN TUBING BELOW RINSE MECHANISM ON NOZZLE 1 AND REPLACED THE TUBING. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATIONS.

    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