BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM QUICK SET

    MDR report key: 1192209 · Received October 7, 2008

    Report

    Report Number
    MW5008580
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    October 7, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    DUE TO TYPE 1 DIABETES, OUR DAUGHTER USES AN INSULIN PUMP, TO MANAGE HER DIABETES. SHE CHANGES HER INFUSION IV SET EVERY 3 DAYS, AS REQUIRED. IN 2008, SHE OPENED NEW INFUSION SET THAT IS SHIPPED TO US BY THE MFR, IN INDIVIDUALLY SEALED CONTAINERS. AS SHE WAS FILLING THE INFUSION LINE WITH INSULIN TO REMOVE THE AIR, IN PREPARATION OF ATTACHING IT TO HER BODY, SHE NOTICED THERE WAS ALREADY BLOOD INSIDE OF THE NEWLY OPENED IV LINE. OUR CONCERN IS THAT THIS INFUSION SET WAS PACKAGED AS A NEW SET TO BE USED BY OUR CHILD; WE DO NOT KNOW WHAT CONTAMINANTS MIGHT BE IN THE BLOOD-LIKE PRODUCT INSIDE THE TUBING. DATE OF USE: 12 HRS; 2008. DIAGNOSIS OR REASON FOR USE: TYPE 1 DIABETES.

    Description of Event or Problem · 1

    THANK YOU FOR YOUR PATIENCE AND FOLLOW UP REGARDING THE DIABETES CARE NEEDS FOR OUR DAUGHTER, AND OUR ATTENTION RELATED TO INFUSION SETS MFG BY MEDTRONIC MINIMED. AS RARE OF AN INCIDENT AS BACK SPLASH MAY BE, IT WAS VERY DIFFICULT AS A PARENT TO REASON RELATIVE AMOUNTS OF INFUSION SETS SOLD AND USED, VERSUS THE ONE NOW PLACED IN MY CHILD'S SKIN WITH BLOOD (OR SOME OTHER RED PATHOGEN) CLEARLY VISIBLE IN THE TUBING OUTSIDE THE INFUSION SET. AS PARENTS, WE PARTOOK IN WHAT WE BELIEVE TO BE THE BEST COURSE OF ACTION, TO ENSURE THE HIGHEST ATTENTION TO DETAIL OF OUR DAUGHTER'S HEALTH NEEDS. OUR INITIAL REQUEST WAS TO DETERMINE THE NATURE OF THE SUBSTANCE; THE REMAINING ACTIONS WERE TO CONFIRM THAT THE SINGLE FEMALE DNA PROFILE OBTAINED IN 2008 WAS A MATCH TO OUR DAUGHTER. THIS DNA PROFILE MATCH WAS CONFIRMED. BASED UPON THE FOLLOWING INFO, WE BELIEVE THERE WAS A USUALLY STRONG BACK SPLASH OF BLOOD UPON INSERTION OF A NEW MEDTRONIC MINIMED PARADIGM INFUSION SET, CAUSING THE BLOOD TO TRAVEL UP THE LENGTH OF THE CANNULA AND INTO THE FIRST 1/2 INCH OF INFUSION TUBING. WE DO NOT BELIEVE AT THIS TIME, THIS WAS DUE TO TAMPERING OR A DEFECTIVE DEVICE. SHOULD NEW INFO ARISE THAT WE ARE NOT AWARE OF, WE WOULD BE HAPPY TO RE-EXAMINE ANY SUPPLEMENTARY EVIDENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM QUICK SET PARADIGM QUICK SET FPA MEDTRONIC MINIMED PARADIGM QUICK SET 2208251

    Patients

    Seq Age Sex Outcome Treatment
    1