BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSULIN PUMP INFUSION SET

    MDR report key: 4080792 · Received September 7, 2014

    Report

    Report Number
    MW5038106
    Event Type
    Injury
    Date Received
    September 7, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 7, 2014
    Manufacturer
    MEDTRONIC
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    QUALITY CONTROL PROBLEM WITH THE MEDTRONIC MIO INSULIN PUMP INFUSION SET - THIS IS THE THIRD TIME WITHIN SEVERAL MONTHS THAT I HAD PROBLEMS WITH THE MEDTRONIC MIO INFUSION SET. THE CANNULA WAS INSERTED CORRECTLY USING THE SELF INSERTER AND WITHIN A COUPLE OF HOURS AFTER INSERTION MY BLOOD SUGAR WENT FROM THE NORMAL RANGE TO CLOSE TO 400. I REMOVED THE INFUSION SET (WHEN REMOVED I COULD SEE THE CANNULA WAS BENT) AND I INSERTED ANOTHER INFUSION. THIS TIME MY BLOOD SUGAR ROSE TO OVER 500. I REMOVED THAT SET (THE CANNULA WAS BENT) AND HAD TO GIVE AN INSULIN INJECTION. THE THIRD INFUSION SET I INSERTED, FROM A DIFFERENT BOX WORKED SO I ASSUME THE CANNULA IS NOT BENT AND I AM RECEIVING MY INSULIN CORRECTLY. THIS IS THE THIRD TIME THIS OCCURED SINCE (B)(6) OF THIS YEAR. I HAVE BEEN WEARING AN INSULIN PUMP FOR OVER 25 YEARS SO I DO KNOW HOW TO INSERT AND OPERATE AN INSULIN PUMP. I HAVE BEEN DIABETIC FOR OBER 50 YEARS AND THANKFULLY KNOW THE SIGNS AND PROBLEMS WITH HIGH BLOOD SUGAR. THE FIRST TIME I ENDED UP IN THE HOSPITAL EMERGENCY ROOM AND THE NEXT TWO TIMES I HAD TO CONTACT THE DOCTOR'S EMERGENCY NUMBER. I HAD NEVER BEEN IN THE HOSPITAL EMERGENCY ROOM IN OVER 50 YEARS BECAUSE OF A HIGH BLOOD SUGAR UNTIL NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547310 INSULIN PUMP INFUSION SET INFUSION SET FPA MEDTRONIC 5049540
    547311 INSULIN PUMP INFUSION SET INFUSION SET LZG MEDTRONIC 5049540
    547312 INSULIN PUMP PUMP LZG MEDTRONIC MIO MMT-943

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening