BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3984296 · Received August 6, 2014

    Report

    Report Number
    2032227-2014-06405
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    May 26, 2014
    Report Date
    July 7, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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

    THE CUSTOMER'S MOTHER REPORTED THAT THERE IS A VARIATION BETWEEN THE BLOOD GLUCOSE AND THE SENSOR READINGS. THE BLOOD GLUCOSE LEVEL WAS 91 MG/DL AND THE SENSOR READING WAS 140 MG/DL. THE INITIAL SENSOR'S LOSS MAY HAVE BEEN DUE TO LACK OF TIME ALLOWED FOR THE UNIT TO DRY AFTER ALCOHOL WAS ADMINISTERED. THERE WAS BLEEDING AT THE INSERTION SITE WITH THE SECOND SENSOR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461036 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR