BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3972391 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05176
    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
    GM
    Reporter Occupation
    OTHER

    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 A BIG DIFFERENCE BETWEEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT THEIR SENSOR GLUCOSE VALUES ARE 80 MG/DL AND BLOOD GLUCOSE VALUES ARE 210 MG/DL. CUSTOMER ALSO REPORTED A CALIBRATION ERROR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446738 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B E014N

    Patients

    Seq Age Sex Outcome Treatment
    1