BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133423 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-94112
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD AN URGENT CARE VISIT DUE TO HIGH BLOOD GLUCOSE OF 425MG/DL, AND HE WAS FEELING NAUSEOUS. THE CALLER ALSO REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING PRIMING. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME AND THE INSULIN DID EXIT. THE HIGH PRESSURE TEST PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234220 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention