BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3120959 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93791
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 28, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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 287 MG/DL, CUSTOMER HAS TREATED WITH MANUAL INJECTION. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 480 MG/DL. CUSTOMER EXPERIENCED KETONES, VOMITING, NO DELIVERY ALARMS AND HIGH BLOOD GLUCOSE. CUSTOMER WAS INSTRUCTED TO TREAT HIGH BLOOD GLUCOSE WITH MANUAL INJECTIONS. ADVISED CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222189 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization