BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3974097 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05263
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    ONE OPENED AND OR USED ENLITE SENSOR WAS PUT THROUGH BICARBONATE BUFFER TEST AND IT FAILED PER SPECIFICATIONS 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

    CUSTOMER REPORTED THE SENSOR GLUCOSE READING AND BLOOD GLUCOSE READING HAVE HAD A GREAT DIFFERENCE, EXACT NUMBERS ARE UNKNOWN. THE INSULIN PUMP WAS ALSO ALARMING BAD SENSOR AND TROUBLESHOOTING WAS PERFORMED FOR THE ALARM. ALARM OCCURRED DURING THE NIGHT AND THAT IS WHEN CUSTOMER NOTICED THE DIFFERENCE IN THE READINGS. THE SENSOR WAS INSERTED FIVE DAYS AGO, ON THE LEFT SIDE OF THE ABDOMEN. ALARM OCCURRED AFTER INITIALIZATION AND AFTER TWO CONSECUTIVE CALIBRATION ERROR ALARMS. CUSTOMER THEN STATED A SECOND BLOOD GLUCOSE READING WAS NOT ENTERED. CUSTOMER WAS ADVISED TO REMOVE THE SENSOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451006 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG04XXJ

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR