BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL E MODULE

    MDR report key: 1880433 · Received October 22, 2010

    Report

    Report Number
    1823260-2010-06338
    Event Type
    Malfunction
    Date Received
    October 22, 2010
    Date of Event
    October 7, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ROCHE DIAGNOSTICS CORPORATION
    Product Code
    JJE
    PMA / PMN Number
    K961481
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE USER RECEIVED QUESTIONABLE FT4 (FREE THYROXINE) RESULTS FOR APPROXIMATELY 600 PATIENT SAMPLES. THE SAMPLES WERE REPEATED AND THE RESULTS DIFFERED AS MUCH AS 50% FROM THE INITIAL RESULT. THE USER DECLINED TO PROVIDE SPECIFIC PATIENT DATA. THE INITIAL RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND THE PATIENTS WERE NOT ADVERSELY AFFECTED. THE FT4 REAGENT LOT NUMBER WAS 15767701. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS A CLOGGED FLOW PATH CAUSING A FLUIDICS FAILURE. HE RAN A LIQUID FLOW PATH CLEAN PROCEDURE. THE USER VERIFIED THE ANALYZER OPERATION BY RUNNING QUALITY CONTROL WITH RESULTS WITHIN SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL E MODULE IMMUNOCHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1