BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4140805 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-33493
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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. PLEASE, SEE MEDWATCH REPORT 2032227-2014-33193.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD STOPPED USING THE SENSORS FOR A WHILE. THE CUSTOMER STATED THAT THE INSULIN PUMP HAD GONE INTO THRESHOLD SUSPEND MODE BECAUSE THE SENSOR GLUCOSE READING WAS 50 MG/DL WHILE THEIR BLOOD GLUCOSE WAS 90 MG/DL, UPON CHECKING. THE CUSTOMER HAD RECALIBRATED, BUT THE SENSOR STILL WOULD NOT FUNCTION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620589 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR