BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1904021 · Received November 21, 2010

    Report

    Report Number
    1823260-2010-06896
    Event Type
    Malfunction
    Date Received
    November 21, 2010
    Date of Event
    November 7, 2010
    Report Date
    January 7, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INSTRUMENT MALFUNCTION WAS DETECTED BY THE FIELD SERVICE REPRESENTATIVE. A SPECIFIC ROOT CAUSE COULD NOT BE IDENTIFIED DUE TO INSUFFICIENT DATA PROVIDED.

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR SODIUM AND POTASSIUM ON THE COBAS 6000 C501 ANALYZER FOR TWO PATIENT SAMPLES STARTING ON (B)(6) 2010. THE USER ONLY PROVIDED RESULTS FOR ONE PATIENT SAMPLE THAT GAVE DISCREPANT RESULTS WHICH OCCURRED ON (B)(6) 2010. THE SAMPLE WAS A PEDIATRIC SERUM SAMPLE. THE ORIGINAL SODIUM RESULT WAS 118 MMOL/L; THE REPEAT RESULT WAS 147 MMOL/L. TH ORIGINAL POTASSIUM RESULT WAS 3.5 MMOL/L; THE REPEAT RESULT WAS 4.5 MMOL/L. THE USER SAID THE ORIGINAL RESULTS FAILED DELTA CHECK AS NOT MATCHING PREVIOUS RESULTS FOR THIS PATIENT SO THEY REPEATED THE PATIENT SAMPLE. THE PATIENT WAS NOT AFFECTED AS THE ORIGINAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE ELECTRODE LOT NUMBERS FOR SODIUM AND POTASSIUM WERE NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE A CAUSE. PERFORMANCE TESTS WERE RUN.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. HOWEVER, INITIAL ANALYSIS REVEALED A DEVICE ANOMALY. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 C501 MODULE CLINICAL CHEMISTRY ANALYZER CEM ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1