BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942879 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04434
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THAT THE SENSORS ARE GIVING INACCURATE READINGS. HE STATED THAT WHEN THE SENSOR GLUCOSE READING WAS 90 MG/DL, THE BLOOD GLUCOSE READING WAS 230 MG/DL. AT THE TIME OF THE CALL THE BLOOD GLUCOSE READING WAS 116 MG/DL AND THE SENSOR GLUCOSE READING WAS 147 MG/DL. IT WAS DETERMINED THAT CUSTOMER WAS NOT FOLLOWING PROPER PROCEDURE AS HE WAS USING THE ENLITE SENSORS WITH A REVEL INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418908 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR