BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4240574 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-34735
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    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 REPORTED BLEEDING EXCESSIVELY FOLLOWING SENSOR INSERTION. CUSTOMER REPORTED THAT SHE REMOVED THE NEEDLE HUB AND IT WAS FILLED WITH BLOOD. CUSTOMER REPORTED THAT THE SITE WAS ACTIVELY BLEEDING AT THE TIME OF THE CALL. CUSTOMER STATED THAT BLOOD WAS VISIBLE ON THE SENSOR CONNECTOR. BLOOD GLUCOSE LEVEL WAS 72 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723745 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A F124U

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR