BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3883704 · Received June 19, 2014

    Report

    Report Number
    2032227-2014-03083
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD
    Reporter Occupation
    PATIENT

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

    Additional Manufacturer Narrative · 1

    INSPECTED 2 OPENED AND USED ENLITE SENSORS AND FOUND 1 OF 2 SENSOR WITH CANULA RETRACTED INSIDE SENSOR BASE. UNABLE TO CONFIRM IF CUSTOMER RECEIVED SENSOR IN THIS CONDITION DUE TO CUSTOMER HAVING RETURNED THEM OPENED AND USED. REMAINING SENSOR PASSED PER SPECIFICATION. NO BENT CANULA WERE OBSERVED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHEN HE WAS REMOVING HIS SENSOR THE NEEDLE CANNULA BROKE AND IT STILL INTO HIS BODY. CUSTOMER STATED THAT IT WAS HARD TO REMOVE IT AND THAT WAS WHEN THE FRACTURE OCCURRED. ADVISED TO ATTEMPT TO REMOVED THE CANNULA, OR SEEK MEDICAL ATTENTION TO REMOVED IT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360213 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR