BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUDATA GTS WITH ADVANTAGE

    MDR report key: 122048 · Received September 19, 1997

    Report

    Report Number
    1823260-1997-00088
    Event Type
    Injury
    Date Received
    September 19, 1997
    Report Date
    September 5, 1997
    Manufacturer
    BOEHRINGER MANNHEIM CORP.
    Product Code
    CFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HEALTH PROFESSIONAL OBTAINED A BLOOD GLUCOSE READING OF 21 MG/DL ON SUSPECT DEVICE. SHE ADMINISTERED D50 AMP TO PATIENT AND REREAD BLOOD GLUCOSE AS 51 MG/DL. SHE STARTED SECOND AMP OF D50 AND GOT LAB RESULTS OF BLOOD GLUCOSE 150 MG/DL. PATIENT HAD TO BE ADMINISTERED INSULIN INTRAVENOUSLY. CONTROLS HAD BEEN IN RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUDATA GTS WITH ADVANTAGE BLOOD GLUCOSE MONITORING SYSTEM CFR BOEHRINGER MANNHEIM CORP. 404 (GTS) 411725 (STRIPS)

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Life Threatening