BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3173953 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94802
    Event Type
    Injury
    Date Received
    June 17, 2013
    Date of Event
    October 3, 2012
    Report Date
    June 4, 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

    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

    THE CUSTOMER REPORTED REGARDING UNEXPLAINED HIGH BLOOD GLUCOSE OF 198MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD SETTINGS WERE CORRECT. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. ADVISED THE CUSTOMER TO CALL BACK WHEN THE TUBING CLAMP ARRIVES. A FOLLOW UP WAS CONDUCTED, AND FOUND THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM DUE TO HIGH BLOOD GLUCOSE. THE CALLER STATED THAT HER GLUCOSE LEVEL WAS TREATED WITH FLUIDS AND INSULIN DRIP, AND THEN RELEASED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273771 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 53 YR Hospitalization