BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3864492 · Received June 10, 2014

    Report

    Report Number
    2032227-2014-02961
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 WAS HOSPITALIZED WITH BLOOD GLUCOSE LEVELS AT OVER 500 MG/DL. THE HOSPITALIZATION WAS DUE TO DIABETES KETOACIDOSIS. CUSTOMER ALSO HAD SINUS AND TACHYCARDIA PROBLEMS. THE CUSTOMER WAS WEARING HER INSULIN PUMP AT THE TIME OF HOSPITALIZATION. IT WAS STATED THAT THE CUSTOMER WAS IN THE HOSPITAL FOR NINE DAYS. IT WAS FURTHER REPORTED THAT THE INSULIN PUMP'S ALARM HISTORY INDICATED NO DELIVERY AND BATTERY OUT LIMIT ALARMS HAD OCCURRED. THE CUSTOMER DECLINED TO RETURN THE INSULIN PUMP FOR ANALYSIS AND WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET, RESERVOIR AND INSULIN. THE CURRENT BLOOD GLUCOSE READING IS 245 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340838 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization