BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2171107 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-82122
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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 CUSTOMER HAD LOW BLOOD GLUCOSE AND PARAMEDICS WERE CALLED. THE CUSTOMER WAS TREATED WITH A GLUCAGON SHOT AND INSULIN DRIP. THE SPOUSE STATED THAT THE SENSORS WERE NOT ALARMING WHEN CUSTOMER'S BLOOD GLUCOSE WAS BELOW THE THRESHOLD OF THE SENSOR. 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-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention