BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4528804 · Received February 19, 2015

    Report

    Report Number
    2032227-2015-07320
    Event Type
    Malfunction
    Date Received
    February 19, 2015
    Date of Event
    February 8, 2015
    Report Date
    February 10, 2015
    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 ISSUES WERE WITH SENSOR GLUCOSE VERSES BLOOD GLUCOSE DIFFERENCES. CUSTOMER STATED THAT THE INSULIN PUMP ALARMED THRESHOLD SUSPEND. CUSTOMER'S BLOOD GLUCOSE READING RANGED BETWEEN 181-200 MG/DL. TROUBLESHOOTING WAS DONE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119473 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG0CVQT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR