BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3930712 · Received July 12, 2014

    Report

    Report Number
    2032227-2014-03727
    Event Type
    Malfunction
    Date Received
    July 12, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. 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

    CUSTOMER'S MOTHER REPORTED THAT THE SENSOR IS GIVING INACCURATE READINGS. SHE REPORTED THAT THE SENSOR GLUCOSE READING WAS 65 MG/DL WHILE THE BLOOD GLUCOSE READING WAS 119 MG/DL. AT THE TIME OF THE CALL THE SENSOR GLUCOSE READING WAS 66 MG/DL WHILE THE BLOOD GLUCOSE READING WAS 113 MG/DL. CUSTOMER'S MOTHER STATED THAT THE SENSOR GLUCOSE GRAPH WAS NOT TRENDING IN THE SAME DIRECTION AS THE BLOOD GLUCOSE. SHE STATED THAT THE SENSOR WAS JUST STARTED THAT DAY AND THAT SHE WAS UNSURE ABOUT CALIBRATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408626 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR