BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1901458 · Received November 17, 2010

    Report

    Report Number
    1823260-2010-06796
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 26, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE RESULTS FOR SODIUM ON THE COBAS 6000 C501 ANALYZER. THE EVENT INVOLVED TWO PATIENT SAMPLES WHICH GAVE DISCREPANT RESULTS. PATIENT SAMPLE 1, THE INITIAL SODIUM RESULT WAS 127 MEQ/L. THE SAMPLE WAS REPEATED ON (B)(6) 2010 WHICH YIELDED A RESULT OF 141 MEQ/L. A CORRECTED REPORT WAS ISSUED WITH THE REPEAT SODIUM RESULT OF 141 MEQ/L. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR HYDRATION, AND THEN DISCHARGED. NO FURTHER INFORMATION WAS AVAILABLE. PATIENT SAMPLE 2, THE INITIAL SODIUM RESULT WAS 126 MEQ/L. THE SAMPLE WAS REPEATED ON (B)(6) 2010 WHICH YIELDED A RESULT OF 143 MEQ/L. A CORRECTED REPORT WAS ISSUED WITH THE REPEAT SODIUM RESULT OF 143 MEQ/L. NO ADVERSE EVENT HAS BEEN ALLEGED REGARDING THIS EVENT. THE ELECTRODE LOT NUMBER FOR SODIUM WAS NOT PROVIDED. THE FIELD SERVICE REPRESENTATIVE DID NOT FIND A CAUSE. HE INSPECTED THE SYSTEM WITH NO PROBLEMS FOUND. PERFORMANCE TESTS WERE PERFORMED WHICH WERE ACCEPTABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1