BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5192695 · Received October 30, 2015

    Report

    Report Number
    2032227-2015-62065
    Event Type
    Malfunction
    Date Received
    October 30, 2015
    Date of Event
    October 13, 2015
    Report Date
    October 13, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    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

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND WHEN HER BLOOD GLUCOSE LEVEL WAS NOT LOW. CUSTOMER'S SENSOR GLUCOSE READING WAS 59 MG/DL BUT HER BLOOD GLUCOSE LEVEL WAS 100 MG/DL. THE CUSTOMER'S SENSOR AND BLOOD GLUCOSE DIFFERENCE WAS NOT WITHIN AN ACCEPTABLE RANGE. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723198 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR