BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4821235 · Received June 5, 2015

    Report

    Report Number
    2032227-2015-17961
    Event Type
    Injury
    Date Received
    June 5, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 16, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    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'S MOTHER REPORTED VIA PHONE CALL THAT THE SENSOR HAD INACCURATE READINGS. CUSTOMER'S BLOOD GLUCOSE WAS 308 MG/DL AND THEIR SENSOR GLUCOSE READ 103 MG/DL. IT WAS ALSO FOUND THE CUSTOMER'S BLOOD GLUCOSE WAS 589 MG/DL AND THEIR SENSOR GLUCOSE READ 75 MG/DL IN ANOTHER INCIDENT. THE MOTHER ALSO REPORTED THE CUSTOMER WAS SICK AT THE TIME OF THE CALL.. THE CUSTOMER WAS ADVISED TO CHANGE THE SENSOR. THE SENSOR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365436 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1