BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4923220 · Received July 17, 2015

    Report

    Report Number
    2032227-2015-22508
    Event Type
    Injury
    Date Received
    July 17, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    CUSTOMER'S MOTHER INITIALLY CALLED TO REPORT THAT THE INSULIN PUMP WAS ALARMING FOR NO SENSOR GLUCOSE AVAILABLE. DURING THE CALL SHE REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE OF 27 MMOL/L; CUSTOMER TREATED WITH THE INSULIN PUMP. THE CALL GOT DISCONNECTED AND NO FURTHER DETAILS COULD BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    465956 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other