BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK SYSTEM

    MDR report key: 1030443 · Received April 17, 2008

    Report

    Report Number
    1823260-2008-03331
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO PT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. PATIENT 1, INITIAL RESULT 0.032 NG/ML, REPEAT <0.010 NG/ML. THE INITIAL RESULTS WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. CUSTOMER REFUSED VISIT FROM FIELD SERVICE REPRESENTATIVE. IF ADDITIONAL INFO IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 2

    TWO PT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. PATIENT 2, INITIAL RESULT 0.047 NG/ML, REPEAT <0.010 NG/ML. THE INITIAL RESULTS WERE REPORTED, THE PATIENTS WERE NOT ADVERSELY AFFECTED. CUSTOMER REFUSED VISIT FROM FIELD SERVICE REPRESENTATIVE. IF ADDITIONAL INFO IS RECEIVED APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS E411 DISK SYSTEM IMMUNOCHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS E411 DISK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR
    2 70 YR