BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX INFUSION SET

    MDR report key: 805682 · Received January 10, 2007

    Report

    Report Number
    2183996-2006-01407
    Event Type
    Injury
    Date Received
    January 10, 2007
    Date of Event
    December 25, 2006
    Report Date
    December 29, 2006
    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 Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT 2 INFUSION SETS FROM THE SAME BOX HAVE TORN IN A ONE WEEK PERIOD. HE STATED THAT ONE OCCURRED ON 12/25/2006. THE PATIENT STATED THAT HE "JUST KNEW" IT WAS TORN. HE REPORTED THAT HE CHECKED HIS BLOOD GLUCOSE VALUES AND THEY WERE ELEVATED (UPPER 200 MG/DL RANGE). HE STATED THAT ON BOTH OCCASIONS, HE CHANGED OUT THE INFUSION SET TUBING AND ADMINISTERED A BOLUS TO REDUCE HIS BLOOD GLUCOSE VALUES. HE STATED HE DID NOT HAVE ANY OF THE COMMON SYMPTOMS OF ELEVATED BLOOD GLUCOSE, BUT THAT HE "JUST DIDN'T FEEL RIGHT". THE PATIENT DID NOT REQUIRE OUTSIDE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE 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 5K027UF

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention INSULIN| INSULIN INFUSION PUMP