BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2021595 · Received March 8, 2011

    Report

    Report Number
    3004209178-2011-80621
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    June 24, 2010
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 DUE TO HYPOGLYCEMIA. THE CUSTOMER STATED THAT THE PERCEIVED CAUSE OF THE EVENT WAS THAT SHE WAS NOT CHECKING HER BLOOD GLUCOSE REGULARLY ENOUGH. THE CUSTOMER ALSO STATED THAT FOLLOWING THE EVENT, SHE SAW A DIETITIAN, WHO ADDED PROTEIN TO HER DIET. SUBSEQUENTLY, THE CUSTOMER HAS NOT EXPERIENCED AS MANY EPISODES OF LOW BLOOD GLUCOSE. 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-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization