BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954126 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04685
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A CALIBRATION ERROR. THE BLOOD GLUCOSE READING WAS 204 MG/DL. THE SENSOR WAS NOT EXPIRED. CUSTOMER STATED THAT THERE WAS NO DELAYED ENTRY OR ENTRY OF AN INCORRECT BLOOD GLUCOSE READING. HE STATED THAT THE ERROR WAS NOT THE RESULT OF THE FIRST CALIBRATION ATTEMPT AFTER INITIALIZATION. CUSTOMER ALSO RECEIVED A BAD SENSOR ALERT AFTER THE INITIALIZATION PERIOD. HE STATED THAT THIS ALERT OCCURRED AFTER A SECOND CONSECUTIVE CALIBRATION ERROR. CUSTOMER WAS ADVISED TO REMOVE AND CHANGE OUT THE SENSOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430941 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A B254U

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR