BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM

    MDR report key: 2103419 · Received May 21, 2011

    Report

    Report Number
    MW5020703
    Event Type
    Injury
    Date Received
    May 21, 2011
    Date of Event
    March 1, 2011
    Report Date
    May 21, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    LZG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT HAS CURRENTLY BEEN ON INSULIN PUMP THERAPY FOR MORE THAN 10 YEARS, 6 OF THOSE YEARS SHE HAS USED MEDTRONIC MINIMED INSULIN PUMPS. PT IS STABLE, COMPLIANT, DELAYED WITH DIABETES CARE AND EXTREMELY SELF AWARE. PT IS ALSO A CERTIFIED CLINICAL RESEARCHER CONDUCTING DIABETES RESEARCH. PT INITIALLY HAD HYPERGLYCEMIC EVENTS DURING THE MINIMED RECALL OF "LOT 8" INFUSION SETS. PT HAS REPORTED NO PROBLEMS UNTIL NOW WITH HER INSULIN PUMP. SHE STARTED HAVING UNCONTROLLED BLOOD GLUCOSE LEVELS IN THE BEGINNING OF MARCH. IN APRIL, SHE CALLED AND REQUESTED A REPLACEMENT PUMP, SINCE ALL OTHER TROUBLESHOOTING HAD BEEN COMPLETED AND SEVERE HIGH AND LOW BLOOD GLUCOSES STILL OCCURRED. SINCE RECEIVING REPLACEMENT PUMP TROUBLES CONTINUE. INSULIN DELIVERY IS QUESTIONABLE. PT ALSO SHOWED THE RESERVOIR WHICH HOLDS THE INSULIN HAS TWO NOTCHES THAT CLIP INTO THE BODY OF THE PUMP, BREAK UPON REMOVAL OF RESERVOIR. THIS MAY OR MAY NOT HAVE ANYTHING TO DO WITH GLUCOSE LEVELS. DATES OF USE: (B)(6) 2001 - (B)(6) 2011. PARADIGM 722, 2008 - PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN PUMP LZG MEDTRONIC PARADIGM 722 512026

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other