BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3111149 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-93411
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    November 19, 2012
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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

    IT WAS REPORTED THAT CUSTOMER WAS HOSPITALIZED FOR FOR HIGH BLOOD GLUCOSE. CUSTOMER STATED THAT HE WAS NOT FEELING WELL AND FELT HIS BLOOD GLUCOSE LEVEL RISE. CUSTOMER WAS ADMITTED FOR TWO DAYS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213001 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 34 YR Hospitalization