BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3930684 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03747
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF 1 OPENED AND USED ENLITE SENSOR SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. HOWEVER, FOUND THE SENSOR CANNULA WAS BENT; UNABLE TO CONFIRM IF THE CUSTOMER RECEIVED THE SENSOR IN SAID CONDITION DUE TO THE SENSOR WAS RETURNED OPENED AND 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. 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.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED ABOUT THE SENSOR'S LIFE BEING SHORTER THAN THE DESIGNATED SIX DAYS. SHE STATED THAT THE SENSOR WAS SHOWING LOW GLUCOSE READINGS. CUSTOMER STATED SHE REMOVED THE SENSOR AND NOTICED IT WAS KINKED. BLOOD GLUCOSE LEVEL IS 113MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408773 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B204U

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR