BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4223062 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46837
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS NOT REQUIRED. UNABLE TO PERFORM INSERTION TEST DUE TO SENSORS BEING OPENED OR USED. INTRODUCER NEEDLE SEPARATED FROM SENSOR.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE EXPERIENCED HIGH BLOOD GLUCOSE OF 412 MG/DL ON (B)(6) 2014; CUSTOMER TREATED WITH INSULIN BOLUS. CUSTOMER REPORTED THAT THE NEEDLE HUB WAS STUCK IN THE SERTER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706169 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B084U

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR