BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 5124009 · Received October 2, 2015

    Report

    Report Number
    2032227-2015-52134
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 8, 2015
    Report Date
    September 14, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    OTHER

    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

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

    Description of Event or Problem · 1

    IT WAS REPORTED OF A CHANGE SENSOR ANOMALY. THE CUSTOMER'S MOTHER REPORTED OF A CHANGE SENSOR ALERT. THE SENSOR WAS IN USE FOR 3 DAYS. THE SENSOR GLUCOSE VERSUS BLOOD GLUCOSE BEGAN ON THE FIRST NIGHT. THERE WAS A DIFFERENCE OF 5 MMOL/L. ON THE THIRD DAY, THERE WAS A DIFFERENCE OF 8 MMOL/L. THE PUMP SUSPENDED INSULIN DELIVERY ACCORDING TO SENSOR GLUCOSE VALUES. THE CHANGE SENSOR ALERT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655717 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A H115P

    Patients

    Seq Age Sex Outcome Treatment
    1