BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2103763 · Received May 18, 2011

    Report

    Report Number
    3004209178-2011-81496
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    March 5, 2011
    Report Date
    May 9, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 DUE TO HIGH BLOOD GLUCOSE LEVELS OVER 400 MG/DL. THE CUSTOMER'S LAST INFUSION SET CHANGE WAS DONE ON THE DAY OF THE EVENT. IT WAS ALSO STATED THAT THE CUSTOMER WAS DIAGNOSED WITH GASTROPARESIS. DURING THE HOSPITALIZATION, THE HOSPITAL STAFF WAS HAVING A DIFFICULT TIME STABILIZING THE CUSTOMER'S BLOOD GLUCOSE LEVELS. THE CUSTOMER'S ENDOCRINOLOGIST RECOMMENDED KEEPING THE CUSTOMER ON THE INSULIN PUMP, RECEIVING INSULIN FROM THE BASAL RATES ONLY. THE CUSTOMER'S BLOOD GLUCOSE DROPPED TO 365 MG/DL, AND THE HOSPITAL DID NOT CHECK HER BLOOD GLUCOSE AFTER THAT. THE CUSTOMER THEN EXPERIENCED HYPOGLYCEMIA, AND WENT INTO A COMA. THE BLOOD GLUCOSE LEVELS WERE TOO LOW TO REGISTER ON THE GLUCOSE METER. IT WAS STATED THAT THE INSULIN PUMP WOULD BE UPLOADED IN CARELINK. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Hospitalization