BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 3942822 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04444
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. SEE MEDWATCH REPORT # 2032227-2014-04445.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP IS ALARMING CALIBRATION ERROR, METER CHECK, AND CHANGE SENOR. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 184MG/DL. ALARMS VERIFIED IN HISTORY. THE SENSOR WAS INSERTED (B)(6) 2014 ON THE ABDOMEN USING THE SERTER. ALARM DID NOT OCCUR AFTER LOST SENSOR OR WAS THE RESULT OF FIRST CALIBRATION ATTEMPT. CUSTOMER HAD ALL READY REMOVED THE SENSOR. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419204 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR