BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP MMT-722NAS

    MDR report key: 1962760 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-80110
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    October 30, 2010
    Report Date
    January 1, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR A SINUS INFECTION CAUSED BY HIGH BLOOD GLUCOSE OF 386MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE CORRECT. THE BASALS, BOLUS, AND DAILY TOTALS ON THE INSULIN PUMP APPEAR TO BE CORRECT. RAN A FIXED PRIME TEST AND THE TEST PASSED SUCCESSFULLY. THE CUSTOMER STATED THAT SHE WEARS THE INFUSION SET NO MORE THAN THREE DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization