BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1032576 · Received April 21, 2008

    Report

    Report Number
    1823260-2008-03447
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 30, 2008
    Report Date
    April 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    FOUR PATIENTS WITH DISCREPANT CREATINE KINASE MB (CKMB) OR TROPONIN T RESULTS REPORTED. PATIENT 1, 3/30 INITIAL CKMB 6.86 NG/ML, REPEAT 41.14 NG/ML. PATIENT 2, FIRST SAMPLE 3/30 INITIAL CKMB RESULT 1.5 NG/ML, REPEAT 2.0 NG/ML; SECOND SAMPLE 3/31 INITIAL CKMB RESULT 1.91 NG/ML, REPEAT 2.3 NG/ML; THIRD SAMPLE 3/31 INITIAL CKMB RESULT <0.1 NG/ML, REPEAT 2.27 NG/ML. PATIENT 3, 3/31 INITIAL TROPONIN T RESULT <0.01 NG/ML, REPEAT 0.12 NG/ML. PATIENT 4, 3/31 INITIAL TROPONIN T RESULT <0.01 NG/ML, REPEAT 0.10 NG/ML. INITIAL RESULTS WERE REPORTED, PATIENTS WERE NOT ADVERSELY AFFECTED. FIELD SERVICE REPRESENTATIVE FOUND ROOT CAUSE TO BE HOLE IN PINCH TUBING THAT WAS REPLACED. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK