BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2232443 · Received August 25, 2011

    Report

    Report Number
    3004209178-2011-82704
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT SHE TOOK MORE INSULIN THAN SHE NEEDED TRYING TO MAXIMIZE THE USE OF THE INSULIN LEFT IN THE TUBING. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WAS TREATED WITH AN INSULIN DRIP WHILE SHE WAS TAKING TO THE HOSPITAL BY THE AMBULANCE. REVIEWED THE PROGRAMMING ON THE INSULIN PUMP AND FOUND THAT THE CUSTOMER WAS DISCONNECTED FROM THE BODY. THE CUSTOMER STATED THAT THERE IS MORE INSULIN IN THE STATUS SCREEN THAN THE RESERVOIR. CHECKED THE BOLUS HISTORY AND SHOWED THAT THE CUSTOMER BOLUSED TWICE IN DIFFERENT TIMES ON THE SAME DAY. HALF HOUR LATER THE CUSTOMER'S GLUCOSE STARTED TO DROP. TWO HOURS LATER HER GLUCOSE WENT DOWN TO 15MG/DL. RAN A SELF TEST TO ENSURE THAT THE INSULIN PUMP WAS FUNCTIONING PROPERLY AND THE TEST PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization