BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1232544 · Received November 13, 2008

    Report

    Report Number
    1823260-2008-08363
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 26, 2008
    Report Date
    November 13, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCED INCORRECT RESULTS FOR SEVERAL ASSAYS AFTER THE MODULE WAS MASKED AND LACTATE REAGENT WAS LOADED AND CALIBRATED. EXACT NUMBER OF PATIENTS INVOLVED AND SPECIFIC PATIENT DATA WERE NOT PROVIDED. AFFECTED ASSAYS INCLUDE: UREA WHICH GAVE NEGATIVE VALUES. TOTAL BILIRUBIN WHICH GAVE RESULTS MULTIPLIED BY A FACTOR OF 10 CALCIUM WHICH GAVE RESULTS MULTIPLIED BY A FACTOR OF 20 CRP WHICH GAVE X INSTEAD OF A NUMERICAL VALUE. AFFECTED ASSAYS WERE RE-CALIBRATED WHICH SOLVED THE PROBLEM. NO RESULTS WERE REPORTED OUTSIDE THE LABORATORY. IF ADDITIONAL INFORMATION IS RECEIVED, APPROPRIATE NOTIFICATION WILL BE PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK