BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4143052 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-30169
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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 REPORTED ADHESIVE ISSUES WITH HIS SENSORS. CUSTOMER'S BLOOD GLUCOSE WAS 99 MG/DL. THE CUSTOMER ALSO REPORTED HIS BLOOD GLUCOSE DECLINED TO 40 MG/DL. THE CUSTOMER WAS TREATED WITH A GLUCAGON SHOT FOR HIS BLOOD GLUCOSE. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603572 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A HG06LR8

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention