BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4171045 · Received October 14, 2014

    Report

    Report Number
    2032227-2014-23743
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    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

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR SENSORS WERE CALIBRATING INCORRECTLY. CUSTOMER STATES THAT THE SENSORS WOULD INFORM THEM THAT THEY WERE EITHER HIGH OR LOW, WHEN HE WAS ACTUALLY STABLE. CUSTOMER DECLINED TROUBLESHOOTING BUT DID NOTICE THAT THE SENSORS HAD EXPIRED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 345 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651734 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG04W3M

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR