BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3163693 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-94642
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    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 WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 704MG/DL. THE CUSTOMER EXPERIENCED PAIN ACROSS THE SHOULDERS, VOMITING, AND FREQUENT URINATION. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE TIME, DATE, AND BASAL RATES WERE CORRECT. HOWEVER, THE BOLUS WIZARD SETTINGS WERE INCORRECT. ASSISTED THE CALLER WITH CORRECTING THEM. REVIEWED THE ALARM HISTORY AND FOUND A LOW RESERVOIR ALARM. INSTRUCTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264308 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 66 YR Hospitalization