BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130801 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94095
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 13, 2013
    Report Date
    May 11, 2013
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S CURRENT BLOOD GLUCOSE READING IS 444 MG/DL. CUSTOMER HAS BEEN HAVING PROBLEMS WITH THE INSULIN PUMP,SHE HAS BEEN RUNNING HIGH. CUSTOMER EXPERIENCING FEELING TIRED, THIRSTY AND FREQUENT URINATION. THE LAST THREE TO FOUR DAYS, RUNNING HIGH FROM 400 TO 500 MG/DL. CUSTOMER TO TREAT WITH LANTIS THRU MANUAL INJECTIONS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231707 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization