BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1231127 · Received November 12, 2008

    Report

    Report Number
    1823260-2008-08353
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    September 11, 2008
    Report Date
    November 12, 2008
    Manufacturer
    HITACHI HIGH TECH CORP.
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS FALLING OUT HIGH ON TWO EXTERNAL PROFICIENCY SURVEY SAMPLES FOR VANCOMYCIN. SURVEY SAMPLE 1: REPORTED SURVEY RESULT 48.6 UG/ML. ACCEPTABLE SAMPLE RANGE IS 32.2 UG/ML TO 48.4 UG/ML. THE SAMPLE WAS REPEATED IN2008, AND RECOVERED 37.6 UG/ML. SURVEY SAMPLE 2: REPORTED SURVEY RESULT 13.0 UG/ML. ACCEPTABLE SAMPLE RANGE IS 8.6 UG/ML TO 12.9 UG/ML. THE SAMPLE WAS REPEATED ON THE SAME DAY, AND RECOVERED 10.6 UG/ML. USER IS NOT AWARE OF ANY PATIENT RESULTS HAVING BEEN REPEATED OR ERRONEOUS. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE CAUSE TO BE POOR CELL RINSING DUE TO A FAILING RINSE WATER VALVE. HE REPLACED THE VALVE, ADJUSTED THE WATER LEVEL TO THE CELLS, ADJUSTED THE EXTERNAL PROBE WASHES, AND ADJUSTED THE SAMPLE PROBE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK