BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1203486 · Received October 17, 2008

    Report

    Report Number
    1823260-2008-07729
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 23, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    USER COMPLAINED THAT A NUMBER OF ASSAY RANDOMLY GIVE RIDICULOUS RESULTS FOR ALT, VALPROATE, CALCIUM, PARACETAMOL, TOTAL BILIRUBIN AND GENTAMICIN. IN EACH CASE, REPEATING THE TEST GAVE THE SAME, WRONG RESULT. IT WAS ALLEGED THE RESULTS BEING PRINTED ARE INCORRECT. BY REPLACING THE REAGENT OR RECALIBRATING, THE PROBLEM DISAPPEARED. THE FSR OBSERVED THE INSTRUMENT APPEARS TO HAVE LOST ITS K FACTOR FOR THESE ASSAYS BUT RECALIBRATING BRINGS THEM BACK. NO INFO WAS PROVIDED TO DETERMINE IF ANY ADVERSE EVENTS OCCURRED. IF ADDITIONAL INFO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK