BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3895417 · Received June 25, 2014

    Report

    Report Number
    2032227-2014-03133
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS PROVIDED BECAUSE ADDITIONAL EVENT DETAILS WERE REPORTED AFTER THE INITIAL REPORT WAS SUBMITTED. THE ADDITIONAL EVENT DETAILS ARE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BROKEN ELECTRODE, BUT IT WAS UNCLEAR WHETHER OR NOT IT HAD BROKEN INSIDE THE PATIENTS SKIN. NOTHING FURTHER WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER CLARIFIED THAT NO PART OF THE SENSOR ELECTRODE HAD BEEN LEFT IN THE BODY, THERE WAS NO INFLAMMATION OR PAIN AT THE INSERTION SITE. THE CUSTOMER HAD NOT CONTACTED A HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369993 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B

    Patients

    Seq Age Sex Outcome Treatment
    1