BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3972380 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05138
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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 GAVE FALSE READINGS AND WERE ITCHY. SHE REPORTED THAT THE INSULIN PUMP HAD SHUT OFF BECAUSE THE SENSOR GLUCOSE READINGS WERE AT 50 MG/DL WHILE THE BLOOD GLUCOSE READING WAS ACTUALLY 120-140 MG/DL. SHE ALSO MENTIONED THAT ONE SENSOR GLUCOSE READING WAS 130 MG/DL WHEN THE BLOOD GLUCOSE READING WAS 49 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447650 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR