BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1241672 · Received November 19, 2008

    Report

    Report Number
    1823260-2008-08560
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    November 5, 2008
    Report Date
    November 19, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT SODIUM RESULTS FOR A TOTAL OF TWENTY ONE PT SAMPLES. THE FOLLOWING FOUR EXAMPLES WERE PROVIDED. UNITS = MMOL/L. SAMPLE 1: INITIAL 156, REPEAT 134. SAMPLE 2: INITIAL 159, REPEAT 134. SAMPLE 3: INITIAL 154, REPEAT 132. SAMPLE 4: INITIAL 140, REPEAT 132. SAMPLE 1 WAS NOT REPORTED. SAMPLES 2 TO 4 WERE REPORTED, CORRECTED REPORTS WERE ISSUED. AND NO INFO WAS PROVIDED TO DETERMINE IF PTS WERE ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE A CELL RINSE MECHANISM THAT WAS OVER FLOWING INTERMITTENTLY. THE CELL RINSE MECHANISM WAS ADJUSTED AND PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER-CEM CEM HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK