BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 1041134 · Received May 8, 2008

    Report

    Report Number
    2183996-2008-00680
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 24, 2008
    Report Date
    April 25, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    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 Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED HER INSULIN INFUSION SET TUBING PARTIALLY SEPARATED NEAR THE LUER LOCK AFTER THE TUBING HAD BEEN IN USE FOR 6 DAYS. SHE STATES SHE NOTICED AFTER THIS SHE FELT MOISTURE AND EXPERIENCED SYMPTOMS OF ELEVATED BLOOD GLUCOSE. SHE SAID HER BLOOD GLUCOSE READING WAS 264 MG/DL WITH HER NORMAL RANGE BEING 80-120 MG/DL. SHE SAID HER SYMPTOMS WERE THIRST AND NAUSEA AND SHE CORRECTED HER READINGS BY CHANGING HER INFUSION SET AND RUNNING A BOLUS OF INSULIN. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND 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 NA 6G094UF

    Patients

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