BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GTS ADVANTAGE SYSTEM

    MDR report key: 88771 · Received May 2, 1997

    Report

    Report Number
    1823260-1997-00034
    Event Type
    Injury
    Date Received
    May 2, 1997
    Date of Event
    April 10, 1997
    Report Date
    April 11, 1997
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A HEALTH CARE PROFESSIONAL STATED THAT AN UNRESPONSIVE PATIENT WITH SEVERE KETOACIDOSIS AND VOMITING WAS GIVEN 2 BAGS OF D-50 BASED ON A BLOOD GLUCOSE RESULT OF 23 WITH THE SUSPECT DEVICE. LABORATORY ANALYSIS OF A SAMPLE TAKEN AT THIS TIME GAVE A RESULT OF 263. DEVICE LABELING INDICATES THAT LOW RESULTS MAY BE OBTAINED WITH THE DEVICE IN CASES OF HYPERGLYCEMIA/HYPEROSMOLARITY WITH OR WITHOUT KETOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GTS ADVANTAGE SYSTEM BLOOD GLUCOSE MONITORING DEVICE CFR BOEHRINGER MANNHEIM CORP. 404 (MONITOR) *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention UNK.