BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3243812 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-95980
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME
    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 BEING IN THE EMERGENCY ROOM DUE TO UNEXPLAINED HIGH BLOOD GLUCOSE OVER 350MG/DL, INTERMITTENT URINE, AND KETONES. THE CALLER STATED THAT HER BLOOD GLUCOSE STARTED TO DROP BY THE TIME SHE ARRIVED AT THE HOSPITAL. THE CALLER STATED THAT SHE WAS GIVING FLUIDS AND THEN RELEASED. THE CUSTOMER MENTIONED THAT AIR BUBBLES WERE NOTED AFTER THE INFUSION SET WAS WORN. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342383 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 48 YR Hospitalization