BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS INTEGRA 400

    MDR report key: 1910225 · Received November 30, 2010

    Report

    Report Number
    1823260-2010-07058
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    September 28, 2010
    Report Date
    November 30, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K951595
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THIS CUSTOMER FAILED EXTERNAL PROFICIENCY SURVEY SODIUM RESULTS FOR TWO OF THE FIVE PROFICIENCY SAMPLES TESTED. SHE REPEATED THE SURVEY SAMPLES, ON (B)(6) 2010, USING THE SAME COBAS INTEGRA 400 ANALYZER. SURVEY SAMPLE 1, INITIAL RESULT WAS 147 MMOL/L. THE SURVEY MEAN WAS 152.7 MMOL/L AND THE REPEAT RESULT WAS 153 MMOL/L (ACCOMPANIED BY A DATA FLAG). SURVEY SAMPLE 2, INITIAL RESULT WAS 129 MMOL/L. THE SURVEY MEAN WAS 134.3 MMOL/L AND THE REPEAT RESULT WAS 134 MMOL/L. THE SODIUM ELECTRODE LOT NUMBER WAS 21592021. THE FIELD SERVICE REPRESENTATIVE DID NOT DETERMINE THE CAUSE OF THE ISSUE. HE RAN PERFORMANCE TESTS WHICH WERE WITHIN SPECIFICATIONS. THE CUSTOMER SUSPECTED THE ISSUE MAY HAVE BEEN CAUSED BY A CONTAMINATED WATER SUPPLY. SHE HAD DECONTAMINATED THE ANALYZER SINCE THE INITIAL PROFICIENCY TESTING WAS PERFORMED. THE CUSTOMER DECLINED ADDITIONAL INVESTIGATION BECAUSE THE COBAS INTEGRA 400 IS SCHEDULED TO BE REPLACED VERY SOON. SHE STATED ISE TESTING WILL NO LONGER BE PERFORMED ON THIS ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS INTEGRA 400 CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1