BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3251024 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96127
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    October 31, 2012
    Report Date
    July 20, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A PHONE CALL WAS CONDUCTED IN ORDER TO FOLLOW UP ON A PREVIOUS CALL THAT THE CUSTOMER MADE FOR UNEXPLAINED HIGH BLOOD GLUCOSE AND FOUND THAT CURRENTLY IS IN THE HOSPITAL, AND NO ADDITIONAL DETAILS WAS GIVING. INITIALLY, THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT CONSISTENTLY DELIVERING INSULIN. THE CUSTOMER STATED THAT THE INFUSION SET AND RESERVOIR WERE CHANGED AS WELL HE HAS USED THE INSULIN IN A MANUAL INJECTION. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353618 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization