BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1221549 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08195
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 11, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT RESULTS FOR GLUCOSE AND CALCIUM. TWO PT SAMPLES WERE KNOWN TO BE AFFECTED. SAMPLE 1 INITIAL GLUCOSE RESULT 372 MG/DL, REPEAT ON ANOTHER ANALYZER GAVE 120 MG/DL. USER WAS NOT SURE IF RESULT WAS REPORTED AND INDICATES THEY ARE NOT AWARE PATIENT WAS TREATED BASED ON THE RESULT. IN 2008, SAMPLE 2 INITIAL CALCIUM RESULT 6.9 MG/DL, REPEAT ON ANOTHER ANALYZER GAVE 9.0 MG/DL PT WAS NOT TREATED DUE TO THIS CALCIUM RESULT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBE WAS PARTIALLY CLOGGED AND OUT OF ADJUSTMENT. HE REPLACED AND ALIGNED THE PROBE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501MODULE CLINICAL CHEMISTRY ANALYZER- CEM CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK