BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2072534 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-81139
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 3, 2011
    Report Date
    April 6, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 550 MG/DL. THE CUSTOMER STATED THAT HE LAST CHANGED HIS INFUSION SET THE DAY BEFORE AND THAT HE TYPICALLY CHANGES OUT HIS INFUSION SET EVERY FOUR DAYS. IT WAS EXPLAINED TO THE CUSTOMER THAT INFUSION SET NEEDS TO BE CHANGED EVERY TWO OR THREE DAYS. THE CUSTOMER THEN STATED THAT WHEN HE PULLED HIS INFUSION SET OUT FROM HIS BODY THAT IT HAD BLOOD ON THE TIP. IT WAS EXPLAINED TO THE CUSTOMER THAT HIS HIGH BLOOD GLUCOSE LEVEL WAS CAUSED BY AN OCCLUDED CANNULA THAT OCCURRED WHEN HE ACCIDENTALLY HIT A CAPILLARY. PROGRAMMING WAS CORRECT. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE FIXED PRIME. NOTHING FURTHER WAS REPORTED.

    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-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization