BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501 MODULE

    MDR report key: 1221498 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08188
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED ERRONEOUS SODIUM RESULTS FOR THIRTEEN PATIENT SAMPLES. FOUR EXAMPLES WERE PROVIDED. SAMPLE 1 INITIAL RESULT 134 MMOL/L, REPEAT 141 MMOL/L. SAMPLE 2 INITIAL RESULT 131 MMOL/L, REPEAT 138 MMOL/L. SAMPLE 3 INITIAL RESULT 134 MMOL/L, REPEAT 140 MMOL/L. SAMPLE 4 INITIAL RESULT 132 MMOL/L, REPEAT 140 MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED OUT. A FIELD CORRECTION FOR THIS ISSUE HAS BEEN INITIATED. IT WAS IDENTIFIED THE CUSTOMER WAS NOT FOLLOWING THE RECOMMENDED ACTIONS SITED IN THE FIELD CORRECTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK