BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC QUICK SET PARADIGM INSULIN INFUSION SET

    MDR report key: 1951042 · Received December 28, 2010

    Report

    Report Number
    MW5018838
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 26, 2010
    Report Date
    December 28, 2010
    Manufacturer
    MEDTRONIC, INC., DIABETES
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE MEDTRONIC PARADIGM INSULIN INFUSION PUMP INFUSION SET -QUICK SET -MMT 357- LOT # 9201048 WAS INSERTED AND WHEN MY BLOOD GLUCOSE CONTINUED TO RISE AND URINE KETONES WERE DETECTED, I TOOK INSULIN BY INJECTION TO LOWER THE GLUCOSE. I THEN NOTED THAT THE INFUSION TUBING WAS LOOSE AT THE INFUSION SET AND I WAS UNABLE TO "LOCK" THE TUBING ONTO THE SET AT THE INFUSION SET. THE LOCKING MECHANISM WAS FAULTY, LEADING TO LOSS OF INSULIN AND DKA. DATES OF USE: (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: #1 - TYPE 1 DIABETES; #2 - TO DELIVER INSULIN SUBCUTANEOUSLY. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUICK SET PARADIGM INSULIN INFUSION SET QUICK SET INFUSION SET FPA MEDTRONIC, INC., DIABETES 9201048

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other