BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 563947 · Received January 3, 2005

    Report

    Report Number
    2183996-2004-01011
    Event Type
    Injury
    Date Received
    January 3, 2005
    Date of Event
    November 27, 2004
    Report Date
    November 30, 2004
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE SINCE 2004 (25 - 30 MMOL/L). PT STATED THAT, WHEN THEY CHANGED THEIR INFUSION SITE, THEY DISCOVERED THAT THEIR CANNULA WAS KINKED. THEY SELF-TREATED BY CHANGING THE SITE, AND DELIVERING BOLUSES OF INSULIN. PT'S BLOOD GLUCOSE REMAINED HIGH THROUGHOUT THE DAY. THEY SOUGHT TREATMENT AT THE HOSPITAL THE FOLLOWING MORNING (2004, AT 5:00AM). PT WAS ADMITTED TO THE HOSPITAL, AND TREATED WITH INSULIN INJECTIONS. AT THE TIME OF THE REPORT, PT WAS STILL IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 4F070UF

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| R INSULIN, INSULIN INFUSION PUMP, DATES OF| TREATMENT: 2004.