BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOSE CALIBRATOR

    MDR report key: 565957 · Received January 5, 2005

    Report

    Report Number
    MW1034293
    Event Type
    Injury
    Date Received
    January 5, 2005
    Date of Event
    June 1, 2004
    Report Date
    January 5, 2005
    Manufacturer
    OLYMPUS
    Product Code
    JIX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CONTACT REPORTED THAT GLUCOSE CALIBRATOR GIVES FALSE READING AND CO SHOULD INFORM ALL USERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOSE CALIBRATOR * JIX OLYMPUS UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention