BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL -TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210309 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37536
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEN 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 BY CUSTOMER THAT HE HAD BEEN HOSPITALIZED BUT WAS NOT DIABETES RELATED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648677 PARADIGM REAL -TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR