BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2170698 · Received July 12, 2011

    Report

    Report Number
    3004209178-2011-82138
    Event Type
    Injury
    Date Received
    July 12, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    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 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 DIABETIC COMA. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE WAS OVER 1000MG/DL AT TIME OF HER ADMISSION. IT WAS STATED THAT THE CUSTOMER WAS NOT USING THE INSULIN PUMP FOR THE PAST TWO WEEKS. IT WAS STATED THAT THE CUSTOMER'S ENDOCRINOLOGIST DOES NOT RECOMMEND THE PT USE INSULIN PUMP THERAPY BECAUSE OF OTHER MEDICAL ISSUES. HOWEVER, THE CUSTOMER REFUSED TO GO BACK ON MANUAL DAILY INJECTIONS. IT WAS ALSO STATED THAT THE CUSTOMER HAS BEEN REQUESTING ADDITIONAL TRAINING. IT WAS STATED THAT THE CUSTOMER'S VISION IS EXTREMELY POOR. NO FURTHER INFO WAS PROVIDED.

    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-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization