BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4011646 · Received August 15, 2014

    Report

    Report Number
    2032227-2014-08353
    Event Type
    Malfunction
    Date Received
    August 15, 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
    VA
    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 COMPLAINED ABOUT SENSOR READING DISCREPANCIES. CUSTOMER STATED THAT THERE IS A DIFFERENCE BETWEEN THE SENSOR GLUCOSE LEVEL AND THE BLOOD GLUCOSE LEVEL. CUSTOMER STATED THAT THIS ISSUE OCCURS AT NIGHT WHILE SLEEPING. CUSTOMER FOLLOWS PROPER PROCEDURE. BLOOD GLUCOSE VALUE IS 195 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489439 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR