BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER DEX

    MDR report key: 504710 · Received December 10, 2003

    Report

    Report Number
    1810909-2003-00431
    Event Type
    Malfunction
    Date Received
    December 10, 2003
    Date of Event
    November 6, 2003
    Report Date
    December 8, 2003
    Manufacturer
    BAYER HEALTHCARE, LLC, DIAGNOSTIC DIVISION
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER DEX BLOOD GLUCOSE METER CFR BAYER HEALTHCARE, LLC, DIAGNOSTIC DIVISION 3952H *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN