BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENSIA ELITE

    MDR report key: 556364 · Received August 18, 2004

    Report

    Report Number
    MW1033062
    Event Type
    Injury
    Date Received
    August 18, 2004
    Date of Event
    February 1, 2004
    Report Date
    August 17, 2004
    Manufacturer
    BAYER CORP.
    Product Code
    CGA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MACHINE OFF BY 25%. SHEET STATES 7%-15% ACCEPTABLE. BAYER REFUSED TO REPLACE GLUCOSE METER WHEN CALLED IN 2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASCENSIA ELITE GLUCOSE METER CGA BAYER CORP. 3885G *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention