BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1221499 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08189
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 20, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    DHA
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED DISCREPANT HCG RESULTS FOR THREE PATIENT SAMPLES. SAMPLE 1 INITIAL RESULT WAS 33.03 MIU/ML, REPEAT RESULT WAS <0.1 MIU/ML AND 0.1 MIU/ML ON ANOTHER ANALYZER. SAMPLE 2 INITIAL RESULT WAS 29.01 MIU/ML, REPEAT 0.1 MIO/ML. SAMPLE 3 INITIAL RESULT 37.36 MIU/ML, REPEAT RESULT WAS <0.1 MIU/ML AND 0.1 MIU/ML ON ANOTHER ANALYZER. INITIAL RESULTS WERE REPORTED. USER DOES NOT HAVE ANY INFORMATION REGARDING TREATMENT, OUTCOMES OR IF THERE WERE ANY ADVERSE EFFECTS. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A PROBLEM WITH THE ANALYZER AND NOTED THE USER WILL MONITOR PATIENT SAMPLES AND IS WORKING WITH THE TECHNICAL SERVICE REPRESENTATIVE CONCERNING POSSIBLE SAMPLE PREPARATION ISSUES. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK