BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4210353 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37537
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 10, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    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 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 BY CUSTOMER THAT HE HAD BEEN HOSPITALIZED BUT WAS NOT DIABETES RELATED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT PROVIDED AT THE TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647241 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A HG05D5U

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR