BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1315986 · Received December 1, 2008

    Report

    Report Number
    1823260-2008-08832
    Event Type
    Malfunction
    Date Received
    December 1, 2008
    Date of Event
    November 13, 2008
    Report Date
    December 2, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS BICARBONATE RESULTS ON ONE PATIENT SAMPLE. THE SAMPLE INITIALLY REPORTED 50 MMOL/L AND REPEATED TWICE AT 28 MMOL/L. THE INITIAL RESULT WAS NOT REPORTED AND THE PATIENT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE CLOGGED CELL BLANK TUBING. THE CELL BLANK TUBING WAS FLUSHED AND THE REACTION CELLS WERE CHECKED. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL P MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK