BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103498 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26484
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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'S MOTHER REPORTED THAT THE INSULIN PUMP WAS RETURNING LOW PREDICT ALERTS WHEN THE BLOOD GLUCOSE LEVEL WAS NORMAL TO HIGH. CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER EXPERIENCED BLOOD GLUCOSE LEVELS OF 563 MG/DL, 493 MG/DL, AND 563 MG/DL THROUGHOUT THE DAY OF THE CALL. BLOOD GLUCOSE LEVEL WAS 465 MG/DL AT THE BEGINNING OF THE CALL, BUT DOWN TO 305 MG/DL BY THE END OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584883 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR