BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4811582 · Received June 2, 2015

    Report

    Report Number
    2032227-2015-17678
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Date of Event
    May 15, 2015
    Report Date
    May 15, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED ENLITE SENSOR FOUND THE SENSOR CANNULA RETRACTED INSIDE OF THE SENSOR; UNABLE TO CONFIRM IF THE CUSTOMER RECEIVED THE SENSOR DAMAGED DUE TO THE CUSTOMER RETURNED OPENED AND USED. ALSO FOUND THE SENSOR WAS WHOLE WITH NO BROKEN OR MISSING PARTS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED A LOST SENSOR. THE BLOOD GLUCOSE READING IS UNKNOWN. CUSTOMER STATES THAT THE CANNULA IS STILL IN THE BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354825 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR