BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4210502 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43484
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IS IT 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

    IT WAS REPORTED THAT THE CUSTOMER HAD LOW BLOOD GLUCOSE LEVELS OF 37 MG/DL. IT WAS REPORTED THAT THE PARAMEDICS WERE CALLED IN TO ASSIST THE CUSTOMER IN BRINGING UP HER BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT ALARM THE CUSTOMER TO LOW BLOOD GLUCOSE READING. THE CUSTOMER REPORTED HAVING ISSUE WITH THE SENSOR GLUCOSE LEVELS READING BEING DIFFERENT FROM THE BLOOD GLUCOSE LEVELS READING. THE CUSTOMER ALSO REPORTED THAT THE THRESHOLD SUSPEND FEATURE OF THE INSULIN PUMP WA NOT ACTIVATED EVENT THOUGH IT WAS SUPPOSED TO. THE CUSTOMER REPORTED THAT THE INSULIN PUMP DID NOT ACTIVATE THE THRESHOLD SUSPEND WITH A SENSOR GLUCOSE READING OF 71 MG/DL WHERE THE ACTUAL BLOOD GLUCOSE LEVEL WAS 37 MG/DL. THE CUSTOMER ALSO REPORTED A BENT SENSOR AFTER TROUBLESHOOTING. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680474 SENSOR ENLITE OZO MEDTRONIC MINIMED MMT-7008A HG07UK4

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR