BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 DISK

    MDR report key: 1030445 · Received April 17, 2008

    Report

    Report Number
    1823260-2008-03332
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    March 27, 2008
    Report Date
    April 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    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 PATIENT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. PATIENT 1, BASELINE RESULT 0.032 NG/ML, REPEAT <0.010 NG/ML. PATIENT HAD TWO ADDITIONAL SAMPLES DRAWN, ONE AFTER 3 HOURS AND ONE AFTER 6 HOURS, EACH SAMPLE WAS REPEATED IN DUPLICATE AND GAVE RESULT OF <0.010 NG/ML EACH TIME. CUSTOMER REFUSED VISIT FROM FIELD SERVICE REPRESENTATIVE. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Description of Event or Problem · 2

    TWO PATIENT SAMPLES WITH DISCREPANT TROPONIN T RESULTS. PATIENT 2, BASELINE SAMPLE TESTED TWICE, GAVE RESULTS OF <0.010 NG/ML EACH TIME. A SECOND SAMPLE WAS DRAWN AFTER THREE HOURS, GIVING INITIAL OF 0.111, REPEAT <0.010 NG/ML. A THIRD SAMPLE WAS DRAWN AFTER SIX HOURS, TESTED TWICE, GIVING RESULTS OF <0.010 NG/ML EACH TIME. CUSTOMER REFUSED VISIT FROM FIELD SERVICE REPRESENTATIVE. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR
    2 74 YR