BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1900959 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06782
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE SODIUM RESULTS FOR 10 PATIENT SAMPLES. OF THE DATA FROM TWO PATIENT SAMPLES THAT WAS PROVIDED, THE RESULTS FOR ONE SAMPLE WERE DISCREPANT. PATIENT SAMPLE 1 INITIAL RESULT WAS 129 MMOL/L WITH A DATA FLAG AND THE REPEAT RESULT WAS 136 MMOL/L. THE INITIAL RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE USER DECLINED TO PROVIDE INFORMATION CONCERNING IF THE PATIENTS WERE AFFECTED. THE LOT NUMBER OF THE SODIUM ELECTRODE WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A MISADJUSTED ISE PROBE THAT WAS RUBBING THE SIDE OF THE ISE BATH. HE READJUSTED THE ISE PROBE. TO VERIFY THE ANALYZER OPERATION, HE RAN PRECISION TESTING WITH CONSISTENT RESULTS AND RAN PERFORMANCE TESTING. THE USER RAN CALIBRATION AND QUALITY CONTROL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR