BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4143386 · Received September 27, 2014

    Report

    Report Number
    2032227-2014-29900
    Event Type
    Injury
    Date Received
    September 27, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    THE CUSTOMER REPORTED DIFFERENCES IN THEIR SENSOR GLUCOSE READINGS VERSUS THEIR BLOOD GLUCOSE READINGS. SENSOR GLUCOSE READING 295, BLOOD GLUCOSE READING 199 MG/DL. THE CUSTOMER ALSO REPORTED LOW BLOOD GLUCOSE LEVELS 42 MG/DL AS WELL AS HIGH BLOOD GLUCOSE LEVELS OF 428 MG/DL. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 251 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603297 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR