BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL D MODULE

    MDR report key: 1133407 · Received August 22, 2008

    Report

    Report Number
    1823260-2008-06361
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 2, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K953239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER EXPERIENCING MULTIPLE PT SAMPLES, GENERATING DISCREPANT ALKALINE PHOSPHOTASE RESULTS WITH A DIFFERENCE OF 50 U/L BETWEEN INITIAL AND REPEAT TESTING SINCE 2008. USER REFUSED TO PROVIDE SPECIFIC DATA. ERRONEOUS RESULTS WERE NOT REPORTED. THE FIELD SERVICE REP DETERMINED THE CAUSE TO BE A FAILURE OF THE FLUIDICS AND AIR IN THE ALK PHOS R2 FLOW PATH. HE REPLACED REAGENT FLOW PATH FITTINGS, AND RE-FLARED TUBING. ALSO REPLACED R2 PIPETTOR MANIFOLD FITTINGS, AND BLEACHED ALK PHOS CHANNEL 16. PERFORMANCE TESTS WERE PERFORMED, AND WITHIN SPECIFICATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK