BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3945845 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04741
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    April 25, 2014
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 CUSTOMER WAS HAVING A RECURRING ISSUE WITH THE SENSORS. CUSTOMER HAD DEVELOPED PUS POCKETS AT SITE OF THE SENSOR. SHE HAD DEVELOPED ALSO ON ABOUT A MONTH AGO AND THEN ABOUT TWO MONTHS AGO, AS WELL. SHE DRAINED THEM HERSELF AND HAD SCHEDULED AN APPOINTMENT WITH HER DOCTOR. BLOOD GLUCOSE LEVEL WAS NOT NOTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425362 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention