BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4056629 · Received September 3, 2014

    Report

    Report Number
    2032227-2014-11568
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    May 24, 2014
    Report Date
    July 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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. REFERENCE MANUFACTURER REPORT NUMBER: 3004209178-2014-96985.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN INFECTION AT THE SITE OF HER SENSOR. CUSTOMER'S BLOOD GLUCOSE WAS 133 MG/DL. THE SITE OF HER INFECTION WAS AT THE ABDOMEN. CUSTOMER STATED THE SIGNS OF INFECTION INCLUDE BLOOD, PUS, AND REDNESS. THE CUSTOMER STATED SHE HAD PROPERLY SANITIZED HER SITE BEFORE THE INSERTION. SHE ALSO REPORTED WAS TAKING A BLOOD THINNER AS PART OF HER MEDICATION. THE CUSTOMER ALSO REPORTED DIFFERENCES BETWEEN HER SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS WHEN SHE WAS WEARING HER SENSORS. SHE ALSO STATED THE IRRITATION MAY BE DUE TO HER SENSOR CANNULA BEING TOO LONG. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538838 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR