BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885137 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85929
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    CUSTOMER COMPLAINED ABOUT HAVING BLOOD GLUCOSE LEVELS FOR THE PAST TWO OR THREE WEEKS. CUSTOMER REPORTED HAVING A SEIZURE AND BEING ASSISTED BY THE PARAMEDICS DUE TO LOW BLOOD GLUCOSE BUT HE WAS NOT HOSPITALIZED AS HE STABILIZED. NO MALFUNCTION DETECTED DURING TROUBLESHOOT. CURRENT BLOOD GLUCOSE IS 215MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360702 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention