BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4191075 · Received October 21, 2014

    Report

    Report Number
    2032227-2014-08468
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SENSOR AND BLOOD GLUCOSE READING WERE DIFFERENT. CUSTOMER'S BLOOD GLUCOSE WAS 102 MG/DL. CUSTOMER DOES NOT HAVE DATA FROM THE INSULIN PUMP. CUSTOMER WILL MONITOR THE ISSUE. SHE WILL CALL BACK WHEN CHANGING THE SENSOR AND ADVISED THAT WE NEED THE DATA FROM THE PUMP TO BETTER EXPLAIN. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670359 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR