BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3111133 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93401
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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

    CUSTOMER CALLED TO REPORTED A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT THE INSULIN PUMP WAS EXPOSED TO TWO CAT SCANS AND MRI. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 436 MG/DL. CUSTOMER WAS TREATED WITH NOVOLOG. BLOOD GLUCOSE AT TIME OF DISCHARGE WAS 242 MG/DL. DISPLACEMENT TEST PASSED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212824 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization