BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3801111 · Received May 8, 2014

    Report

    Report Number
    3004209178-2014-84522
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    CUSTOMER'S DAUGHTER REPORTED HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CALLER STATED THAT PHYSICIAN WANTED MEDTRONIC AWARE OF THE INCIDENT. CALLER WANTED TO MAKE SURE THAT THE INSULIN PUMP WAS NOT MALFUNCTIONING. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 970 MG/DL. CUSTOMER WAS COMPLAINING OF STOMACH PAIN. DIAGNOSED DIABETES KETOACIDOSIS. HOSPITAL TREATED WITH INSULIN DRIP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277496 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization