BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1257488 · Received December 4, 2008

    Report

    Report Number
    1823260-2008-08928
    Event Type
    Malfunction
    Date Received
    December 4, 2008
    Date of Event
    November 18, 2008
    Report Date
    December 4, 2008
    Manufacturer
    HITACHI HIGH TECH CORP.
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS CREATININE RESULTS FOR WEEKS. CUSTOMER IS UNSURE OF HOW MANY SAMPLES WERE INVOLVED. THE FOLLOWING SEVEN PT EXAMPLES WERE PROVIDED WHICH OCCURRED 2008. UNITS OF MEASURE ARE IN MG/DL. SAMPLE 1: INITIAL 0.0/REPEAT 3.5. SAMPLE 2: 0.2/3.7. SAMPLE 3: 0.2/1.3. SAMPLE 4: 0.0/0.7. SAMPLE 5: 0.0/0.7. SAMPLE 6: 0.1/0.8. SAMPLE 7: 0.6/3.5. CUSTOMER IS NOT AWARE OF ANY ERRONEOUS PT RESULTS THAT WERE REPORTED AND NO INFO WAS PROVIDED TO DETERMINE IF ANY PTS WERE ADVERSELY AFFECTED. THE FIELD SVC REP DETERMINED THE CAUSE TO BE A WEAK GEAR PUMP. THE GEAR PUMP ASSEMBLY WAS REPLACED AND THE FILTERS IN THE SYRINGE WATER LINES WERE CLEANED. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPEC.

    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