BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1082534 · Received July 23, 2008

    Report

    Report Number
    1823260-2008-05691
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    July 11, 2008
    Report Date
    July 23, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER REPORTS ONE PATIENT WITH DISCREPANT HCG-B RESULTS. INITIAL RESULT 0.601 MIU/ML, REPEAT >10000 MIU/ML, DILUTED AND REPEATED, GAVE RESULT OF 24283 MIU/ML. INITIAL RESULT WAS REPORTED, PATIENT NOT ADVERSELY AFFECTED. THE FIELD SERVICE REP WAS UNABLE TO DUPLICATE THE ISSUE. PERFORMANCE TESTS WERE PERFORMED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK