BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 6203904 · Received December 26, 2016

    Report

    Report Number
    2032227-2016-53188
    Event Type
    Malfunction
    Date Received
    December 26, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 1, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 VIA PHONE CALL TO HAVE EXPERIENCED SENSOR GLUCOSE VERSUS BLOOD GLUCOSE DIFFERENCES WITH THRESHOLD SUSPEND. CUSTOMER'S SENSOR GLUCOSE WAS 59 AND BLOOD GLUCOSE WAS 175 MG/DL. CUSTOMER WAS EDUCATED ON THRESHOLD SUSPEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854232 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG1EF5S

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR