BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3852332 · Received June 5, 2014

    Report

    Report Number
    2032227-2014-02903
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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 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 STATED SHE WAS HAVING PROBLEMS INSERTING HER SENSOR. WHEN SHE TRIED TO REMOVE THE NEEDLE FROM THE SENSOR, SHE WAS NOT ABLE TO DO SO. THE SENSOR DID NOT RECOGNIZE THAT THE TRANSMITTER WAS CONNECTED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 176 MG/DL. SHE BELIEVES THAT THE SENSOR CANNULA HAS BROKEN IN HER BODY ON THE LEFT SIDE OF HER ABDOMEN AND THAT IT BROKE WHILE SHE WAS TRYING TO REMOVE THE SENSOR. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328891 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C214U

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR