BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C501MODULE

    MDR report key: 1052522 · Received May 22, 2008

    Report

    Report Number
    1823260-2008-04261
    Event Type
    Malfunction
    Date Received
    May 22, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT WITH DISCREPANT CREATININE KINASE RESULT. INITIAL RESULT WAS REPORTED, PT WAS NOT ADVERSELY AFFECTED. INITIAL RESULT 100 U/L, UPON DILUTION SAMPLE GAVE RESULT OF 13300 U/L. FIELD SERVICE REP UNABLE TO DETERMINE ROOT CAUSE, COULD NOT DUPLICATE PROBLEM. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR NOREPINEPHRINE N/P 250MLS/DAY| SEE ATTACHMENT IN CASE| LINEZOLID N/P 300 MLS/HR