BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4112213 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-28214
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    OTHER

    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

    IT WAS REPORTED THAT THE CUSTOMER HAD A THRESHOLD SUSPEND ALARM ON THE INSULIN PUMP AND A HIGH READING ON THE METER. CUSTOMER'S CURRENT BLOOD GLUCOSE LEVEL WAS 151 MG/DL. IT WAS EXPLAINED THAT THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS WILL BE CLOSE, BUT RARELY MATCH DUE TO HOW GLUCOSE TRAVELS IN THE BODY. IT WAS ALSO EXPLAINED THAT THERE MAY BE LARGER DIFFERENCES AFTER MEALS, BOLUS DELIVERY, OR WHEN ARROWS ARE PRESENT ON THE SENSOR GRAPH. CUSTOMER REPORTED THAT THE PUMP WAS READING THRESHOLD SUSPEND BELOW 40 MG/DL AND HER BLOOD GLUCOSE LEVEL WAS READING 538 TO 600 MG/DL. CUSTOMER STATED THERE WERE SOME ARROWS ON THE GRAPH SCREEN. CUSTOMER'S CURRENT SENSOR GLUCOSE READING WAS 40 MG/DL. SENSOR GLUCOSE AND BLOOD GLUCOSE DIFFERENCE IS NOT WITHIN AN ACCEPTABLE RANGE. CUSTOMER WAS ADVISED TO REMOVE AND REPLACE THE SENSOR. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592457 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR