BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3951362 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88087
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 22, 2014
    Report Date
    June 24, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS HOSPITALIZED. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE HOSPITALIZATION WAS 525 MG/DL AND HAD DIABETIC KETOACIDOSIS. SIGNIFICANT EVENT LEADING TO THE EMERGENCY ROOM VISIT WAS THAT THE CUSTOMER WAS FEELING SICK TO THE STOMACH. THE CUSTOMER WAS IN AN ACCIDENT AND THEY WERE DRIVING AT THE TIME OF THE ACCIDENT. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE EMERGENCY ROOM VISIT. THE CUSTOMER'S BLOOD GLUCOSE AT THE TIME OF THE PHONE CALL WAS 166 MG/DL. THERE WERE BATTERY OUT LIMIT AND BAD BATTERY ALARMS FOUND IN THE HISTORY OF THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428947 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization