BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK

    MDR report key: 1063002 · Received June 18, 2008

    Report

    Report Number
    1823260-2008-04813
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 27, 2008
    Report Date
    June 18, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONE PATIENT WITH DISCREPANT BETA HCG RESULTS. INITIAL RESULT 0.268 MLU/ML. SAME SAMPLE REPEATED THREE TIMES GAVE 268.7 (DILUTED 1:20), 284.7, AND 267.3 MLU/ML (DILUTED 1:20). INITIAL RESULT WAS NOT REPORTED. THE FIELD SERVICE REPRESENTATIVE WAS UNABLE TO DETERMINE ROOT CAUSE. PERFORMANCE TEST PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR