BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2970511 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91170
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 5, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD AN URGENT CARE VISIT DUE TO HIS HIGH BLOOD GLUCOSE OF 350MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT FUNCTIONING PROPERLY. THE CALLER STATED THAT THE CUSTOMER WAS THROWING UP AND HAD KETONES FOR THE PAST TWO WEEKS. INITIALLY THE CALLER STATED THAT THE CUSTOMER WAS GETTING NO DELIVERY AND LOW BATTERY ALARMS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74480 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 15 YR Hospitalization