BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3933467 · Received July 14, 2014

    Report

    Report Number
    2032227-2014-03794
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED TWO OPENED/USED ENLITE SENSORS AND PERFORMED BICARBONATE BUFFER TEST. BOTH SENSORS PASSED THE TEST WITH ACCURATE 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. PLEASE MEDWATCH REPORT # 2032227-2014-03793.

    Description of Event or Problem · 1

    CUSTOMER COMPLAINED ABOUT RECEIVING LOST SENSOR ALARMS ON MULTIPLE SENSORS AND STATED THAT WHEN HE CHANGED THEM, HE NOTICED THE SENSOR CANNULA BEING BENT. DURING TROUBLESHOOT CUSTOMER STATED THAT THE INSULIN PUMP IS NOT COMMUNICATING WITH THE TRANSMITTER AND ASSISTED ON SELECTING THE FIND LOST SENSOR OPTION. CUSTOMER STATED THAT PREVIOUS SENSORS WERE INSERTED IN THE ABDOMEN BUT HE ISERTED A NEW ONE IN THE LEG. PATIENT'S BG IS 118 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411206 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR