BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4256313 · Received November 17, 2014

    Report

    Report Number
    2032227-2014-53629
    Event Type
    Malfunction
    Date Received
    November 17, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 20, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MEDWATCH 203227-2014-46313 AND 2032227-2014-41969. 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 STATES THAT THE PREVIOUS NIGHT SHE HAD A SENSOR READING OF 45 MG/DL AND A BLOOD GLUCOSE OF 155 MG/DL. THE CUSTOMER RECEIVED SEVERAL THRESHOLD SUSPEND ALARMS. DURING ONE OF THE INCIDENTS IT DID NOT RE-START AND THE CUSTOMER HAD A BLOOD GLUCOSE OF 200 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT FOR THE HIGH BLOOD GLUCOSE. THE CUSTOMER IS WEARING HER SENSOR ON HER ARM. THE CUSTOMER WAS EXPLAINED THE ISSUES WITH OFF LABEL USE. ADVISED CUSTOMER TO CALL BACK TO TROUBLESHOOT FOR SUGAR GLUCOSE VERSUS BLOOD GLUCOSE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741853 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR