BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1040627 · Received May 7, 2008

    Report

    Report Number
    1823260-2008-03866
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS FOR MULTIPLE ASSAYS. ONLY ONE PT EXAMPLE FOR CALCIUM PROVIDED. INITIAL RESULT 12.4 MG/DL, REPEAT 7.8 MG/DL. INITIAL RESULT WAS NOT REPORTED. THE FILED SERVICE REPRESENTATIVE DETERMINED CLOGGED HIGH CONCENTRATION TUBING TO BE THE CAUSE AND REPLACED THE TUBING. PERFORMANCE TESTS PERFORMED WHICH 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 P MODULE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK