BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3981377 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06102
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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

    CUSTOMER CALLED REPORTING BLOOD AT HIS SENSOR INSERTION SITE THERE WAS BLOOD ALL THE WAY UP THE CANNULA AND ON THE CONNECTORS. CUSTOMER'S BLOOD GLUCOSE IS 124 MG/DL. THE SITE IS NOT ACTIVELY BLEEDING. THERE IS BLOOD ON THE SENSOR CONNECTORS. HE INSERTS IN THE ABDOMEN AREA. THE SENSOR WAS NOT TUGGED OR PULLED AFTER INSERTION. CUSTOMER FOLLOWS PROPER INSERTION METHODS. HE WAS ADVISED TO REPLACE THE SENSOR SINCE BLOOD ON THE CONNECTOR CAN POSSIBLY DAMAGE THE TRANSMITTER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458318 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A F034U

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR