BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANALYTICAL P MODULE

    MDR report key: 1172478 · Received September 19, 2008

    Report

    Report Number
    1823260-2008-07013
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 25, 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
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    USER IS INTERMITTENTLY GETTING LOW RESULTS FOR MULTIPLE ASSAYS THAT WILL REPEAT HIGHER. TOTAL NUMBER OF PATIENT SAMPLES INVOLVED IS UNKNOWN. ONE EXAMPLE FOR ALT IS PROVIDED. INITIAL RESULT WAS 3 U/L, WHICH WAS QUESTIONED BY THE DOCTOR. USER REPEATED THE SAMPLE WITH A RESULT OF 84 U/L. PATIENT WAS NOT TREATED BASED ON THE INITIAL RESULT. THE FIELD SERVICE REPRESENTATIVE DETERMINED THE SAMPLE PROBE WAS MISALIGNED, AND PERFORMED SAMPLE PROBE VERTICAL AND HORIZONTAL ALIGNMENTS. ON SUBSEQUENT VISIT, THE SAMPLE PROBE WAS REPLACED. PERFORMANCE TESTS WERE PERFORMED WHICH WERE WITHIN SPECIFICATION.

    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