BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1172469 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07019
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER RECEIVING HIGH RESULTS FOR BICARBONATE FOR SIX PATIENT SAMPLES. ONE ESTIMATION OF RESULTS WAS PROVIDED. INITIAL RESULT 36 MMOL/L, REPEAT 25 OR 24 MMOL/L. NO ERRONEOUS RESULTS WERE RELEASED. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE REAGENT 1 TUBING WAS BROKEN AND REPLACED THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANALYTICAL D MODULE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK