BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4212431 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-38009
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 26, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 IN THE HOSPITAL WITH GASTROPARESIS. IT WAS NOTED THAT THE CUSTOMER NOTICED A DIFFERENCE BETWEEN THE SENSOR GLUCOSE READINGS VERSUS THE BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT THE SENSOR WAS READING 183 MG/DL WHEN THE BLOOD GLUCOSE READINGS WERE 171 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680533 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A HG083KN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization