BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESTIGE GLUCOSE MONITOR

    MDR report key: 173126 · Received March 20, 1998

    Report

    Report Number
    173126
    Event Type
    Injury
    Date Received
    March 20, 1998
    Date of Event
    January 22, 1998
    Report Date
    January 24, 1998
    Manufacturer
    HDI HOME DIAGNOSTICS, INC
    Product Code
    CFR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    GLUCOSE MONITOR DELIVERED FALSE READINGS, LOW/HIGH INCONSISTENTLY. PT TREATING LOW BLOOD SUGARS WHEN BLOOD SUGARS WERE NOT LOW RESULTING IN PT'S HYPERGLYCEMIA. MONITOR WAS RETURNED TO HDI WK OF 1/23/1998.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTIGE GLUCOSE MONITOR BLOOD GLUCOSE MONITOR CFR HDI HOME DIAGNOSTICS, INC UNAVAILABLE UNAVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R