BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5143238 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-56017
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    August 1, 2015
    Report Date
    August 24, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION WAS PERFORMED ON ONE OPENED AND USED ENLITE SENSOR FOUND THE SENSOR CANNULA WAS RETRACTED INSIDE OF THE SENSOR BASE, NO BROKEN OR MISSING PARTS WERE OBSERVED DURING OUR ANALYSIS. UNABLE TO CONFIRM IF HE CUSTOMER RECEIVED THE SENSOR DAMAGED DUE TO THE SENSOR WAS RETURNED OPENED AND USED.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT WHEN THE SENSOR WAS REMOVED FROM THE PATIENT'S BODY, ONLY HALF OF THE ELECTRODE WAS FOUND. CUSTOMER INDICATED THAT THE REPLACEMENT OF THE SENSOR FAILED. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673390 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A D285N

    Patients

    Seq Age Sex Outcome Treatment
    1