BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLUCOMETER ELITE

    MDR report key: 12584 · Received April 6, 1994

    Report

    Report Number
    MW1001475
    Event Type
    Malfunction
    Date Received
    April 6, 1994
    Report Date
    April 5, 1994
    Manufacturer
    MILES, INC.
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE RESULTS OBTAINED FROM THIS DEVICE ARE 7-10% HIGHER THAN RESULTS OBTAINED BY USING OTHER INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE CFR MILES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 *