BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 866020 · Received June 14, 2007

    Report

    Report Number
    2183996-2007-00896
    Event Type
    Injury
    Date Received
    June 14, 2007
    Date of Event
    June 3, 2007
    Report Date
    June 4, 2007
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K033892
    Removal / Correction Number
    Z-1116/1146-6
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER REPORTED THAT THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE DUE TO THE INFUSION TUBING SEPARATING AT THE LUER CONNECTION. THE PATIENT DISCOVERED THE SEPARATION WHEN SHE FELT MOISTER FROM INSULIN LEAKAGE. THE MOTHER STATED THAT THE PATIENT'S BLOOD GLUCOSE ELEVATED TO 15 MMOL/L (270 MG/DL) AND SHE CHANGED HER INFUSION TUBING AND BOLUSED TO LOWER HER BLOOD GLUCOSE. THE PATIENT'S NORMAL BLOOD GLUCOSE RANGE IS 9-11 MMOL/L (162-198 MG/DL). THE PATIENT "DIDN'T FEEL GOOD" AND "FELT ICKY AND THIRSTY" DUE TO THE ELEVATED BLOOD GLUCOSE. THE MOTHER STATED THAT THEY WERE NOT AWARE OF THE RECALL. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. ULTRAFLEX 6K171UF

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention INSULIN| INSULIN INFUSION PUMP