BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3173978 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94794
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    June 20, 2012
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    INITIALLY, THE CUSTOMER CALLED REQUESTING ASSISTANCE WITH CHANGING HER BASAL RATES AS HER BLOOD GLUCOSE WAS GETTING HIGH. THE CUSTOMER STATED THAT SHE IS HAVING APPOINTMENT WITH HER DOCTOR IN A WEEK. A FOLLOW UP WAS CONDUCTED, AND FOUND THAT THE CUSTOMER WAS IN THE EMERGENCY ROOM DUE TO DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OF 480MG/DL. THE CALLER MENTIONED THAT THE CANNULA WAS BENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273092 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization