BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLUCOMETER ELITE

    MDR report key: 80052 · Received March 28, 1997

    Report

    Report Number
    80052
    Event Type
    Injury
    Date Received
    March 28, 1997
    Date of Event
    February 20, 1997
    Report Date
    March 26, 1997
    Manufacturer
    MILES, INC.
    Product Code
    CFR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BLOOD GLUCOSE METER GAVE FALSE HIGH BLOOD SUGAR LEVELS REPEATEDLY. INSULIN GIVEN TO REDUCE INSULIN LEVEL. PT WENT INTO DIABETIC COMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLUCOMETER ELITE GLUCOSE MONITOR CFR MILES, INC. 3901 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L