BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5143247 · Received October 10, 2015

    Report

    Report Number
    2032227-2015-56010
    Event Type
    Malfunction
    Date Received
    October 10, 2015
    Date of Event
    August 27, 2015
    Report Date
    August 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RELIABILITY ANALYSIS INSPECTED ONE OPENED/USED ENLITE SENSOR AND FOUND SENSOR CANNULA BENT INSIDE THE SENSOR. UNABLE TO CONFIRM THAT THE CUSTOMER RECEIVED THE SENSOR IN SAID CONDITION DUE TO PRODUCT BEING RETURNED OPENED/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. 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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE SENSOR WAS INSERTED BUT THE TRANSMITTER WAS NOT BLINKING WHEN CONNECTED TO THE SENSOR. THE CUSTOMER REMOVED THE SENSOR AND FOUND THAT THE CANNULA WAS MISSING. BLOOD GLUCOSE VALUE IS UNKNOWN. CUSTOMER DECLINED TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673533 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A F125P

    Patients

    Seq Age Sex Outcome Treatment
    1