BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 569757 · Received January 17, 2005

    Report

    Report Number
    2183996-2004-01066
    Event Type
    Malfunction
    Date Received
    January 17, 2005
    Date of Event
    December 5, 2004
    Report Date
    December 19, 2004
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED THAT THE INFUSION SETS, FROM THIS LOT, HAVE BEEN LEAKING. THEY INDICATED THAT THE LEAKAGE TYPICALLY OCCURS AFTER 1 - 2 DAYS USE. PT STATED THAT THEIR BLOOD GLUCOSE HAS BEEN ELEVATED (253 - 512 MG/DL), WHICH THEY SELF-TREATED BY CHANGING THEIR INFUSION SET, AND DELIVERING INSULIN VIA INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 4D086UF

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR NA.| INSULIN, INSULIN INFUSION PUMP, DATE OF TREATMENT: