BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103489 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26377
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER BLOOD GLUCOSE VALUE WAS 408 MG/DL; TREATING WITH INSULIN BOLUS DOSE. CUSTOMER STATED THAT HER BLOOD GLUCOSE VALUE IS HIGH DUE TO NOT GIVING HERSELF ENOUGH INSULIN BOLUS. CUSTOMER STATED THAT THE INSULIN PUMP IS WORKING AND DECLINED TO TROUBLESHOOT THE INSULIN PUMP. CUSTOMER ALSO REPORTED SHE IS RECEIVING LOST SENSOR ALERTS. CUSTOMER RECEIVED A NEW TRANSMITTER; THE WRONG TRANSMITTER ID IS NOT PROGRAMMED IN THE INSULIN PUMP. THE LED LIGHT ON THE TRANSMITTER IS NOT BLINKING WHEN CONNECTED TO THE SENSOR. CUSTOMER CHARGED THE TRANSMITTER AND RECONNECTED IT TO THE SENSOR IT IS STILL NOT COMMUNICATING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584880 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A G114U

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR