BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1193372 · Received October 7, 2008

    Report

    Report Number
    1823260-2008-07398
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 13, 2008
    Report Date
    October 7, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED A LOW CALCIUM RESULT FOR ONE PATIENT SAMPLE. INITIAL RESULT GAVE 2.4 MG/DL; REPEAT GAVE 8.4 MG/DL. DISCREPANT RESULT WAS NOT REPORTED. THE FIELD SERVICE REP WAS UNABLE TO DETERMINE A ROOT CAUSE. 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 ROCHE DIAGNOSTICS C501

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK