BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4103485 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26360
    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
    CO
    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

    DURING A FOLLOW UP CALL, THE CUSTOMER STATED THAT THEY HAD ISSUES WITH THE SENSORS. THE CUSTOMER STATED THAT THE INSULIN PUMP WOULD ALERT LOW BLOOD GLUCOSE AND THE DEVICE WOULD WANT TO GO INTO THRESHOLD SUSPEND MODE. BUT, WHEN THE CUSTOMER WOULD CHECK, THEIR BLOOD GLUCOSE WOULD BE 90 MG/DL. THE CUSTOMER STATED THAT THE SENSOR GLUCOSE VALUES AND THE BLOOD GLUCOSE VALUES WOULD NEVER BE CLOSE. THE CUSTOMER STATED THAT THE ALARMS WOULD HAPPEN ESPECIALLY AT NIGHTS AND THEIR BLOOD GLUCOSE WOULD BE 100 MG/DL. THE CUSTOMER STATED THAT THEY STOPPED USING THE INSULIN PUMP ALTOGETHER APPROXIMATELY A MONTH PRIOR TO THE PHONE CALL. AT THE TIME OF THE PHONE CALL THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584148 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR