BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4191270 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-41548
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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. 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

    IT WAS REPORTED THAT THE CUSTOMER WAS BLEEDING QUITE A BIT AFTER INSERTING A SENSOR. HER BLOOD GLUCOSE WAS 174MG/DL AT THE TIME OF REPORTING. SHE STATED THAT SHE COULD SEE BLOOD ON THE SENSOR CONNECTOR. IT WAS DISCOVERED THAT THE CUSTOMER HAD INSERTED THE SENSOR PROPERLY AND IN AN ACCEPTABLE AREA. SHE WAS ADVISED TO REPLACE THE SENSOR, AND WAS TOLD THAT IT WOULD BE REPLACED. NO EQUIPMENT IS BEING RETURNED. NO ADDITIONAL INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669155 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A F114U

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR