BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6054265 · Received October 25, 2016

    Report

    Report Number
    2032227-2016-34251
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 3, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSMITTER DID NOT BLINK WHEN IT WAS CONNECTED TO THE SENSOR. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. SITE BEGAN TO BLEED WHEN THE SENSOR WAS INSERTED. CUSTOMER MENTIONED THE ELECTRODE WAS MISSING WHEN THE SENSOR WAS REMOVED FROM THE BODY. CUSTOMER WAS ADVISED THE SENSOR WILL BE REPLACED. CUSTOMER WILL NOT BE RETURNING THE SENSOR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706492 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G286P

    Patients

    Seq Age Sex Outcome Treatment
    1