BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4240680 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49683
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 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

    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

    WHILE REPORTING ISSUES WITH A LOST SENSOR ALARM, CUSTOMER REPORTED HAVING A BLOOD GLUCOSE LEVEL OF 400 MG/DL EARLIER IN THE DAY OF THE CALL. BLOOD GLUCOSE LEVEL WAS 364 MG/DL AT THE TIME OF THE CALL. TROUBLESHOOTING DID NOT FIND ANY ERROR ALARMS IN THE INSULIN PUMP'S HISTORY AND WAS ABLE TO CORRECT THE LOST SENSOR ALARM. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723407 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG08LT4

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR