BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3932978 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03780
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 THE SENSOR AND BLOOD GLUCOSE SHOW A BIG DIFFERENCE. CUSTOMER'S SENSOR GLUCOSE WAS 60 MG/DL AND BLOOD GLUCOSE READING WAS 160 MG/DL TROUBLESHOOTING WAS PERFORMED. SENSOR AGE WAS AT DAY FIVE AND TWELVE HOURS. CUSTOMER WAS ADVISED OF POSSIBLE CAUSES. CUSTOMER CURRENT BLOOD GLUCOSE WAS 151 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411330 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C264U

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR