BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3954122 · Received July 23, 2014

    Report

    Report Number
    2032227-2014-04664
    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
    NM
    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.

    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 LOW READINGS. THE CANNULA WAS FOUND BENT. IT COULD NOT BE CONFIRMED THAT THE CUSTOMER RECEIVED THE SENSOR IN SAID CONDITION AS THE SENSOR WAS RETURNED OPENED AND USED.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED RECEIVING CALIBRATION ERROR ALERS. THE BLOOD GLUCOSE READING WAS 291 MG/DL AND THE CUSTOMER TREATED WITH THE PUMP. SHE WAS ADVISED THAT USE OF THE SENSORS ON A PERSON OF AGE 16 IS CONSIDERED OFF LABEL USE. SHE STATED THAT THERE WAS NO ENTRY OF AN INCORRECT BLOOD GLUCOSE READING OR DELAYED ENTRY AND THAT THE ALERT WAS NOT RESULT OF THE FIRST CALIBRATION ATTEMPT AFTER INITIALIZATION. SHE STATED THEY RECEIVED A BAD SENSOR ALERT AFTER THE INTIALIZATION PERIOD. SHE ALSO STATED THAT THE TRANSMITTER DOES NOT BLINK WHEN CONNECTED TO THE SENSOR. THE SENSOR WAS REMOVED AND THEY FOUND THAT THE CANNULA WAS BENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430577 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG04DTB

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR