BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2233959 · Received August 31, 2011

    Report

    Report Number
    3004209178-2011-82803
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    August 19, 2011
    Report Date
    August 20, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P890022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PROD 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 HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER WAS VOMITING, NAUSEA, AND CONFUSED. ATTEMPTED TO TROUBLESHOOT, BUT THE INSULIN PUMP KEPT ALARMING NO DELIVERY WHEN THE RESERVOIR HAS LESS THAN 40.0 UNITS. IT WAS STATED THAT THE CUSTOMER TRIED TO DISCONNECT AT THE QUICK RELEASE, BUT THE ADHESIVE PATCH AND CANNULA WERE STILL ON THE CUSTOMER'S BODY. IT WAS STATED THAT THE CUSTOMER WAS ON AN INSULIN DRIP AT TIME OF CALL. NO FURTHER INFO 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 41 YR Hospitalization