BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1061602 · Received June 17, 2008

    Report

    Report Number
    1823260-2008-04774
    Event Type
    Malfunction
    Date Received
    June 17, 2008
    Date of Event
    May 23, 2008
    Report Date
    June 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    ONE PT SAMPLE WITH DISCREPANT RESULTS FOR TSH AND FREE T4. INITIAL TSH RESULT GAVE 0.046 UIU/ML; REPEATED TWICE GIVING 2.22 AND 2.21 UIU/ML. INITIAL FREE T4 GAVE 0.03 NG/DL; REPEATED THREE TIMES GIVING 1.00, 1.06 AND 1.07 NG/DL. ERRONEOUS RESULTS WERE REPORTED. PTS NOT ADVERSELY AFFECTED. ALTHOUGH THE EXACT ROOT CAUSE WAS NOT DETERMINED, THE FIELD SERVICE REP SUSPECTED DIRTY REACTION CELL AND THE SAMPLE SYRINGE SEAL. HE CLEANED, ADJUSTED AND VERIFIED ALIGNMENT OF ALL REAGENT AND SAMPLE PROBES. ADJUSTED, VERIFIED CELL RINSE WATER LEVEL, AND REPLACED SAMPLE SYRINGE SEAL AND REACTION CELLS. PERFORMANCE TESTS WERE PERFORMED AND WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER- CEM CEM ROCHE DIAGNOSTICS E601

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR