BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4844550 · Received June 15, 2015

    Report

    Report Number
    2032227-2015-18973
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 27, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND MODE DUE TO AN INACCURATE SENSOR GLUCOSE READING. THE CUSTOMER'S BLOOD GLUCOSE WAS 110 MG/DL, COMPARED WITH THE SENSOR READING OF 75 MG/DL. THE THRESHOLD SUSPEND LIMIT WAS SET TO 56 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP KEPT ON ALARMING THROUGH THE NIGHT. HE WAS ADVISED THAT HE MAY HAVE SLEPT ON THE SENSOR, WHICH MAY HAVE CAUSED THE LOW ALERTS. THE CUSTOMER DECLINED TO BE TRANSFERRED FOR TROUBLESHOOT ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387272 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR