BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2081265 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-81222
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 A BROKEN KNEE THAT WAS NOT DIABETES-RELATED. THE CUSTOMER STATED THAT SINCE THAT EVENT HIS BLOOD GLUCOSE LEVELS HAVE BEEN RUNNING HIGH. THE CUSTOMER THEN STATED THAT THE DOCTOR HAD TRIED TO TEST THE INSULIN PUMP BY PROGRAMMING A BOLUS DELIVERY FOR NINE UNITS OF INSULIN. THE CUSTOMER ADDED THAT HIS BOLUS WIZARD WAS SET UP WITH A 6 HOUR ACTIVE INSULIN TIME AND 15.3 UNITS OF ACTIVE INSULIN. IT WAS EXPLAINED TO THE CUSTOMER THAT THE INSULIN PUMP WOULD NOT ESTIMATE ANY INSULIN DELIVERY AS A RESULT. IT WAS FURTHER EXPLAINED TO THE CUSTOMER THAT TESTING FOR INSULIN DELIVERY ON THE INSULIN PUMP SHOULD ALWAYS BE DONE THROUGH THE FIXED PRIME WHILE THE CUSTOMER IS DISCONNECTED SO THAT IT WOULD NOT AFFECT THE BOLUS ESTIMATE. 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-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization