BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3833443 · Received May 27, 2014

    Report

    Report Number
    3004209178-2014-85040
    Event Type
    Injury
    Date Received
    May 27, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH DIABETIC KETOACIDOSIS. THE HOSPITALIZATION FOLLOWED A PROBLEM WITH THE INFUSION SET ATTACHED TO THE INSULIN PUMP NOT STICKING TO HIS BODY. THE CUSTOMER HAD A FLU AND WAS SWEATING A LOT, POSSIBLY AFFECTING THE EFFECTIVENESS OF THE ADHESIVE. AT THE TIME OF HOSPITALIZATION, THE CUSTOMER WAS WEARING THE INSULIN PUMP AND HIS BLOOD GLUCOSE WAS 700 MG/DL. THE CUSTOMER HAS USED MANUAL INJECTION TO MANAGE BLOOD GLUCOSE LEVELS FOLLOWING THE HOSPITALIZATION. NO FUTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310599 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization