BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 E601 MODULE

    MDR report key: 1221548 · Received November 5, 2008

    Report

    Report Number
    1823260-2008-08194
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Date of Event
    September 14, 2008
    Report Date
    November 5, 2008
    Manufacturer
    HITACHI HIGH TECH. CORP.
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER RECEIVED AN INCORRECT LOW TSH RESULT FOR ONE PT SAMPLE. THE SAMPLE INITIALLY RESULTED AS 0.119 UIU/ML. IN 2008, THE SAMPLE REPEATED TWICE AT 38.02 UIU/ML AND 37.86 UIU/ML. THE INITIAL RESULT WAS REPORTED AND THE PT WAS NOT ADVERSELY AFFECTED. THE FIELD SERVICE REPRESENTATIVE DETERMINED A POSSIBLE CAUSE TO BE FAULTY SAMPLING DUE TO USAGE OF MICROCUPS. HE COULD NOT CONFIRM MICROCUP USAGE ON THIS SAMPLE. PRODUCT LABELING DOES NOT SUPPORT THE USE OF MICROCUPS. PERFORMANCE TESTS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBAS 6000 E601 MODULE IMMUNOCHEMISTRY ANALYZER- CEM JJE HITACHI HIGH TECH. CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR