BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1231132 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08354
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 12, 2008
    Manufacturer
    HITACHI HIGH TECH CORP.
    Product Code
    JJE
    PMA / PMN Number
    P953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS BUN, CREATININE, AND POTASSIUM RESULTS FOR ONE PT SAMPLE. THE SAMPLE INITIALLY GAVE RESULTS OF 73 MMOL/L FOR BUN, 9.5 MG/DL FOR CREATININE AND 7.1 MMOL/L FOR POTASSIUM. THE SAMPLE WAS REPEATED ON ANOTHER ANALYZER AND GAVE 27 MMOL/L FOR BUN, 0.7 MG/DL FOR CREATININE AND 4.6 MMOL/L FOR POTASSIUM. THE ERRONEOUS PT RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE A DEFECTIVE GEAR PUMP. HE REPLACED THE GEAR PUMP AND ADJUSTED THE PRESSURE. HE ALSO CHECKED THE RINSE NOZZLES FOR PROPER FILLING, CHECKED THE SQUEEGEES, AND CHECKED TO MAKE SURE THE RINSE BATHS ARE WASHING OFF THE OUTSIDE OF THE PROBES PROPERLY. 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