BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 528962 · Received May 28, 2004

    Report

    Report Number
    MW1032178
    Event Type
    Injury
    Date Received
    May 28, 2004
    Date of Event
    April 1, 2004
    Report Date
    May 18, 2004
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    BEGINNING IN 2004, PT BEGAN HAVING MANY PROBLEMS USING THE MINIMED QUICK SET PLUS INFUSION SET THAT PT HAD BEEN USING WITH THE MINIMED PARADIGM INSULIN PUMP. THIS PROBLEM CONTINUED FOR 1 MONTH IN 2004, WHEN PT DISCONTINUED USE OF THE QUICK SET PLUS INFUSION SET. THE TAPE ON THE INFUSION SET DID NOT ADHERE WELL, AND ALMOST NEVER LASTED THE THREE DAYS IT WAS SUPPOSED TO STAY ON. SEVERAL TIMES, THE ADHESION BECAME SO POOR, THE INFUSION SET PULLED OFF ENTIRELY, AND PT HAD TO PREMATURELY CHANGE THE ENTIRE INFUSION SET. A HUG WASTE OF TIME, MONEY, AND SUPPLIES. AS OF APRIL, 2004, PT HAD TROUBLE WITH THE CATHETER PART OF THE TUBING OF THE INFUSION SET KINKING AT A 90 DEGREE ANGLE UNDER THE SKIN. THE ONLY WAY TO DETERMINE THE TUBING WAS KINKED WAS TO REMOVE THE ENTIRE ADHESION PART OF THE INFUSION SET, WHICH WAS EXTREMELY WASTEFUL. WHEN THE CATHETER TUBING KINKED, THE FLOW OF INSULIN WOULD BE DISRUPTED, OR COMPLETELY BLOCKED, AND PT WOULD NOT BE RECEIVING THE INSULIN PT USES TO LIVE. FOR APROXIMATELY THE ENTIRE MONTH BLOOD SUGARS WERE RUNNING BETWEEN 200-400 MG/DL, WHEN NORMALLY THEY ARE BETWEEN 70-140 MG/DL. PT CEASED USE OF THE QUICK SET PLUS IN EARLY THE NEXT MONTH, AFTER A GREAT DEAL OF EXASPERATION, FRUSTRATION, AND FEELING AWFUL FOR A MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED INFUSION SET FOR INSULIN PUMP FPA MEDTRONIC MINIMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention