BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4860845 · Received June 22, 2015

    Report

    Report Number
    2032227-2015-18976
    Event Type
    Malfunction
    Date Received
    June 22, 2015
    Date of Event
    June 4, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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

    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 WAS 100 MG/DL. TROUBLESHOOTING WAS DONE. PRODUCT IS NOT BEING RETURNED OR REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403423 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR