BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1221501 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08191
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    October 14, 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 ONE PATIENT SAMPLE. INITIAL RESULT OF 13.42 MIU/ML WAS REPORTED TO THE PHYSICIAN WHO DID NOT BELIEVE THIS RESULT WAS POSSIBLE AND ASKED FOR REPEAT TESTING. SAMPLE WAS REPEATED AND GAVE RESULT OF 0.1 MIU/ML. SAME SAMPLE WAS ALSO REPEATED ON ANOTHER ANALYZER AT THE SITE AND GAVE A RESULT OF <0.1 MIU/ML. USER STATED THE PATIENT HAD TO RETURN FOR ANOTHER HCG TEST, BUT DID NOT PROVIDE ANY INFORMATION REGARDING ANY ADVERSE TREATMENT EFFECTS. NO DATA WAS PROVIDED FOR THIS ADDITIONAL TESTING. THE FIELD SERVICE REPRESENTATIVE COULD NOT FIND A PROBLEM WITH THE ANALYZER AND DETERMINED THE ISSUE WAS DUE TO A PROBLEM WITH THE PATIENT SAMPLE. 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