BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2823267 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-90624
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    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 BEING HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 532MG/DL, AND THE INSULIN PUMP WAS SUSPENDED WHILE STAYING AT THE HOSPITAL. ADVISED THE CALLER THAT THE BASAL RATES WILL START DELIVERING WITH WHATEVER CURRENT RATE SHOULD BE, AND DO NOT ATTEMPT TO MAKE UP FOR MISSED INSULIN. THE CUSTOMER STATED THAT THE DOCTOR BELIEVES IT WAS A BAD SITE ISSUE AND NOT THE INSULIN PUMP ISSUE. SUGGESTED THE CUSTOMER TO CALL BACK IF ISSUES PERSIST. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Hospitalization