BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4780997 · Received May 19, 2015

    Report

    Report Number
    2032227-2015-16122
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 28, 2015
    Report Date
    April 29, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    THE CUSTOMER REPORTED THAT HE HAD A THRESHOLD SUSPEND ALARM AND DIFFERENCES BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS WHILE SLEEPING. CUSTOMER'S BLOOD GLUCOSE WAS 250 MG/DL AND HIS SENSOR GLUCOSE WAS BELOW 60 MG/DL. CUSTOMER ALSO HAD A LOST SENSOR AND THRESHOLD SUSPEND ALARMS ON OTHER NIGHTS. CUSTOMER IS USING THE SENSOR OFF-LABEL IN THE UPPER-THIGH. CUSTOMER DECLINED TRANSFER TO THE HELPLINE AND WILL UPLOAD TO CARELINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325141 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR