BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1241671 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08558
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 14, 2008
    Report Date
    November 19, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT URINE TOTAL PROTEIN RESULTS ON THREE PT SAMPLES. THE SAMPLES WERE TESTED FOR A SITE TO SITE METHOD COMPARISON STUDY. NO PT RESULTS WERE REPORTED. ALL SAMPLES WERE REPEATED TWICE IN 2008 ON A DIFFERENT ANALYZER. SAMPLE 1 INITIALLY RECOVERED 15 MG/DL AND REPEATED AS 35 MG/DL AND 31 MG/DL. SAMPLE 2 INITIALLY RECOVERED 34 MG/DL AND REPEATED AS 43 MG/DL AND 44 MG/DL. SAMPLE 3 INITIALLY RECOVERED 56 MG/DL AND REPEATED AS 75 MG/DL AND 73 MG/DL. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER-JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK