BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3920850 · Received July 8, 2014

    Report

    Report Number
    3004209178-2014-86539
    Event Type
    Injury
    Date Received
    July 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    THE CUSTOMER REPORTED CALLING THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE OF 40 MG/DL. THE CUSTOMER STATED THAT THEY WOKE UP WITH BLOOD GLUCOSE OF 140 MG/DL, ATE BREAKFAST AND TOOK A BOLUS. AN HOUR AND A HALF LATER THEY STARTED YAWNING A LOT SO THEY CHECKED THE BLOOD GLUCOSE AND IT WAS 380 MG/DL. THEY TOOK A CORRECTIVE BOLUS. AN HOUR LATER THE BLOOD GLUCOSE DROPPED TO 40 MG/DL SO THEY DRANK MILK AND CALLED THEIR DOCTOR'S OFFICE. WHILE ON THE PHONE, THE NURSE NOTICED THAT THE CUSTOMER WAS HAVING A PROBLEM, SO THE NURSE CALLED THE PARAMEDICS. THE CUSTOMER WAS GIVEN CONCENTRATED GLUCOSE GEL AND AN IV. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME WHEN THE PARAMEDICS WERE CALLED. THE CUSTOMER NEEDED ASSISTANCE WITH CHANGING THE BASAL RATES ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398432 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention