BEUDAMED
    FDA Adverse Event Summary report: N

    SENSOR ENLITE

    MDR report key: 3981973 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06115
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 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

    ONE OPENED AND USED SENSOR WAS INSPECTED AND A BICARBONATE BUFFER TEST WAS PERFORMED. THE SENSOR FAILED PER SPECIFICATION DUE TO HIGH READINGS.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S SENSOR READINGS SIGNIFICANTLY DIFFERED FROM HER BLOOD GLUCOSE. THE CUSTOMER'S BLOOD GLUCOSE WAS 166 MG/DL, BUT HER SENSOR READ 90 MG/DL. THE CUSTOMER ALSO REPORTED AN INSTANCE OF HER BLOOD GLUCOSE BEING 115 MG/DL WHILE HER SENSOR READ 84 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458050 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008B HG03C8H

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR