BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1030605 · Received April 16, 2008

    Report

    Report Number
    1823260-2008-03286
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED DISCREPANT RESULTS WHEN SWITCHING REAGENT LOTS FOR TROPONIN T TESTING. ONE SAMPLE GAVE INITIAL RESULT OF 0.033 NG/ML, SAMPLE REPEATED TWICE NEXT DAY, WITH DIFFERENT LOT GAVE 0.045 AND 0.048 NG/ML. ERRONEOUS RESULT WAS NOT REPORTED. IF ADD'L INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALTZER - CEM MMI ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK