BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3903429 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86192
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    December 28, 2013
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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 REPORTED A HOSPITALIZATION DUE TO DEHYDRATION AND HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE LEVEL AT THE TIME OF THE EVENT WAS 420 MG/DL TO 450 MG/DL, CUSTOMER IS UNSURE. CUSTOMER WAS INCOHERENT AND NAUSEATED. CUSTOMER ALSO HAD AN INFECTION ON HER FOOT. HOSPITAL WITH FLUIDS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379437 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 58 YR Hospitalization