BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2140422 · Received June 16, 2011

    Report

    Report Number
    3004209178-2011-81838
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE CUSTOMER REPORTED HAVING MULTIPLE HYPOGLYCEMIC REACTIONS AND WANTS TO CHANGE HER SETTINGS AS A RESULT. THE CUSTOMER STATED THAT SHE HAD A GLUCAGON INJECTION, AND THE PARAMEDICS WERE CALLED TO HER HOME. IT WAS STATED THAT THE CUSTOMER IS IN POST SURGERY AND HAD PNEUMONIA. THE CUSTOMER ALSO REPORTED THAT RECENTLY SHE WAS FOUND UNCONSCIOUS AT HER DESK AND WAS TAKEN TO THE HOSPITAL DUE TO HYPOGLYCEMIA. IT WAS STATED THAT THREE MONTHS AGO THE CUSTOMER HAD CHANGED THE CARBOHYDRATES RATIO ON BOLUS WIZARD. IT WAS STATED THAT SHE WAS EXPERIENCING LOW GLUCOSE LEVEL FOR THE PAST THREE MONTHS. IT WAS STATED THAT THE CUSTOMER'S MOST RECENT GLUCOSE READING WAS 79MG/DL. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING, TIME, AND DATE WERE CORRECT. THE CUSTOMER STATED THAT THERE ARE 15.0 UNITS MORE OF INSULIN IN THE STATUS SCREEN THAN WHAT IS IN THE RESERVOIR. RAN A DISPLACEMENT TEST AND THE TEST PASSED. 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-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization