BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC MINIMED

    MDR report key: 2536613 · Received April 10, 2012

    Report

    Report Number
    MW5025018
    Event Type
    Injury
    Date Received
    April 10, 2012
    Date of Event
    April 10, 2012
    Report Date
    April 10, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PLEASE NOTE THAT THE ABOVE INFO CHECKED IN THE BOXES OTHER THAN ¿PRODUCT PROBLEM¿ AND ¿LIFE THREATENING¿ DO NOT APPLY. THE REASON THEY ARE CHECKED IS THAT THE SYSTEM WOULD NOT ALLOW ME TO MOVE TO THE NEXT SECTION UNLESS ALL THE BOXES WERE CHECKED. BELOW IS THE REASON FOR THE COMPLAINT: MINIMED PARADIGM INFUSION SETS ARE POORLY DESIGNED, AND POORLY MANUFACTURED. PERIOD. THEY HAVE AN INHERENT DESIGN FLAW WHERE THE TUBING MEETS THE RESERVOIR, WHICH CAUSES THE HOSE TO KINK AND NOT ALLOW INSULIN TO PASS THROUGH THE TUBING. THIS FLAW CAUSES THE PUMPS TO GIVE A ¿NO DELIVERY¿ MESSAGE, WHICH REQUIRES THE USER TO CHANGE THE ENTIRE INFUSION SET FAR MORE OFTEN THAN SHOULD BE NECESSARY. THIS PROBLEM IS NOT ONLY COSTLY, BUT BECAUSE THE INSULIN IS NOT BEING DELIVERED PROPERLY PTS WILL SUFFER FROM EXTREMELY HIGH BLOOD SUGARS VERY QUICKLY. THIS PUTS PTS AT RISK FOR DIABETIC COMPLICATIONS FURTHER DOWN THE ROAD, AND IN THE SHORT TERM DIABETIC COMA AND PERHAPS EVEN DEATH. OVER THE YEARS THIS PROBLEM WOULD OCCUR NOT NEARLY AS OFTEN AS IT DOES NOW, MAYBE ONCE VERY FEW MONTHS, BUT IT WAS NOT WHAT I WOULD CONSIDER A HUGE PROBLEM, THAT IS, UNTIL RECENTLY. NOW IT SEEMS AS THOUGH NEARLY EVERY ONE OF THE INFUSION SETS ARE BAD. IN FACT, 9 OF THE LAST 10 HAVE BEEN. THE MOST RECENT LOT TO HAVE THIS FLAW IS LOT MMT-397, (LOTS 6 AND 9) BUT I WOULD ASSUME THAT MOST IF NOT ALL INFUSION SETS THAT ARE MANUFACTURED IN THE SAME WAY HAVE AT LEAST THE POTENTIAL FOR THE EXACT SAME MALFUNCTION. WHEN CONTACTING THE COMPANY ON NUMEROUS OCCASIONS TO NOTIFY THEM OF THE PROBLEMS, MORE OFTEN THAN NOT THEY HAVE BEEN HIGHLY RESISTANT TO DO ANYTHING ABOUT THE ISSUE. IN FACT, IT IS MY OBSERVATION THAT THEY WILL DO EVERYTHING POSSIBLE TO NOT EVEN ACKNOWLEDGE THE DESIGN FLAW. THEY INSTEAD WILL CLAIM THAT THE ISSUE IS A PROBLEM OF ¿USER ERROR¿ OR ATTRIBUTE THE ISSUE TO ¿SCAR TISSUE¿ OR PERHAPS A ¿LOW BATTERY¿, RATHER THAN REPLACE THE PRODUCT, OR EVEN MORE APPROPRIATELY, CORRECT THE OBVIOUS DESIGN FLAW. THE PROBLEM IS, AND ALWAYS WAS, A POOR DESIGN, AND IT NEEDS TO BE CHANGED IMMEDIATELY OR MINIMED RUNS THE RISK OF CRIMINAL LIABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MINIMED PARADIGM QUICK SET INFUSION SET FPA MEDTRONIC MINIMED 9201724
    2 MEDTRONIC MINIMED PARADIGM QUICK SET INFUSION SET FPA MEDTRONIC MINIMED 2210437

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening