BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS E411 RACK SYSTEM

    MDR report key: 1204059 · Received October 16, 2008

    Report

    Report Number
    1823260-2008-07699
    Event Type
    Malfunction
    Date Received
    October 16, 2008
    Date of Event
    September 29, 2008
    Report Date
    October 16, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER STATES THAT HE GOT AN HCG RESULT OF >10,000 MIU/ML THAT THEY PUT BACK ON FOR AN AUTOMATIC DILUTION OF 1:50 AND OBTAINED A VALUE OF 32.59 MIU/ML. HE RAN THE SAME SAMPLE ON ANOTHER ANALYZER AND GOT A VALUE OF 103,604 MIU/ML. RESULT OF 103, 604 WAS REPORTED OUT. THE FIELD SERVICE REPRESENTATIVE STATED THE USER HAD REPLACED THE DILUENT BEFORE HIS ARRIVAL ON SITE AND INSTRUMENT WAS OPERATIONAL. THE FIELD SERVICE REPRESENTATIVE SUSPECTED SHORT SAMPLE OF DILUENT DUE TO A BUBBLE. THE FIELD SERVICE REPRESENTATIVE VERIFIED LEVEL SENSE AND INSTRUMENT OPERATION.

    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