BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2002556 · Received February 16, 2011

    Report

    Report Number
    3004209178-2011-80434
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 13, 2011
    Report Date
    February 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETES KETOACIDOSIS. THE BLOOD GLUCOSE READING AT TIME OF CALL WAS 352MG/DL. THE MOTHER STATED THAT THE EVENTS LEADING TO CUSTOMER'S ADMISSION WAS BENT CANNULAS. THE MOTHER STATED THAT THE CUSTOMER EXPERIENCED HIGH GLUCOSE FOR THE PAST MONTH. IT WAS STATED THAT THE CUSTOMER HAD A BACK UP PLAN AND HAS TREATED WITH MANUAL INJECTIONS. TROUBLESHOOTING WAS PERFORMED. IT WAS STATED THAT THE CUSTOMER CHANGED THE INFUSION SET THE DAY BEFORE TO RESOLVE THE ISSUE. REVIEWED ALL THE PROGRAMMING AND THE BOLUS, BASAL, TIME, AND DAILY TOTALS WERE CORRECT. RAN A FIXED PRIME AND HIGH PRESSURE TEST AND THE INSULIN PUMP PASSED THE TESTS. NO FURTHER INFORMATION 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-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Hospitalization