BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3945586 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04529
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED SENSORS. CUSTOMER COMPLAINED ABOUT THE SEN-SERTER. TWO SENSORS RECEIVED WITH BENT CANNULAS. UNABLE TO CONFIRM IF CUSTOMER RECEIVED SENSOR IN SAID CONDITION, DUE TO CUSTOMER RETURNED THE SENSORS OPENED AND USED.

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNING PRODUCT 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. PLEASE SEE MEDWATCH REPORT # 3004209178-2014-87649.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SHE LOST A SENSOR AND INSERTED ANOTHER SENSOR. SHE WAS UNABLE TO GET A READING WITH NEW SENSOR SO SHE TOOK IT OUT AND STATED IT WAS BENT. SHE WAS TRYING TO INSERT ANOTHER SENSOR; SHE NOTICED THE SERTER DOES NOT COVER THE WHOLE SENSOR. CUSTOMER WAS ADVISED TO PRESS THE GREEN BUTTON AND THE NEEDLE HUB WAS RELEASED. CUSTOMER'S BLOOD GLUCOSE WAS 42 MG/DL, TREATED WITH ORANGE JUICE, CRACKERS, AND HONEY. CUSTOMER DECLINE DO TO TROUBLESHOOT THE INSULIN PUMP. CUSTOMER STATED THE SENSOR IS FULLY INSERTED BUT THE NEEDLE HUB WAS STUCK IN THE SERTER. FOUND THE SENSOR WAS BENT. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425070 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A A244U

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR