BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR ANALYTICS CORE

    MDR report key: 1063645 · Received June 19, 2008

    Report

    Report Number
    1823260-2008-04855
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 19, 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

    CUSTOMER REPORTS A PROBLEM WITH A PATIENT UREA RESULT BEING REPORTED TO THEIR HOST AS A HDL RESULT FOR ANOTHER PATIENT SAMPLE. NO ADVERSE EVENTS REPORTED. THE INVESTIGATIONAL UNIT VERIFIED THE CUSTOMER'S COMPLAINT. A FIELD CORRECTION FOR THIS ISSUE HAS BEEN INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MODULAR ANALYTICS CORE CLINICAL CHEMISTRY ANALYZER - JJE JJE ROCHE DIAGNOSTICS MODULAR CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK