BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2170702 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82142
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 228MG/DL AND WAS TREATED WITH AN INSULIN DRIP. THE CUSTOMER STATED THAT SHE HAD ELEVATED KETONE LEVELS, NAUSEA, FREQUENT URINATION, VOMITING, AND EXTREME THIRST. THE CUSTOMER STATED THAT THE DOCTOR CHANGED HER BASAL RATES. TROUBLESHOOTING WAS PERFORMED. THE BUTTONS WERE UNRESPONSIVE AND THE TIME WAS NOT ADVANCING. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization