BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 577705 · Received February 18, 2005

    Report

    Report Number
    2183996-2005-00057
    Event Type
    Malfunction
    Date Received
    February 18, 2005
    Date of Event
    January 19, 2005
    Report Date
    January 19, 2005
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT INFUSION SET SEPARATED, CAUSING INSULIN LEAKAGE. PT INDICATED THAT, AS A RESULT, THEIR BLOOD WAS ELEVATED (193-357 MG/DL). PT SELF-TREATED BY CHANGING THEIR INFUSION SET, TO RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 3O129UF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN DATE OF TREATMENT: NA| INSULIN, INSULIN INFUSION PUMP,