BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 4103238 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26495
    Event Type
    Injury
    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
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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

    IT WAS REPORTED THAT THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS HAD DISCREPANCIES AND THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE READING WAS 85 MG/DL, SO SHE TOOK A GLUCOSE TABLET. SHE REPORTED THAT, INSTEAD OF RAISING HER BLOOD GLUCOSE, THE READING DROPPED TO 69 MG/DL. SHE ATE OTHER THINGS AND BROUGHT THE BLOOD GLUCOSE READING UP TO 500 MG/DL. IT WAS UNCLEAR WHEN THIS OCCURRED OR HOW SHE TREATED THE HIGH BLOOD GLUCOSE. SHE THEN STATED THAT HER BLOOD GLUCOSE READING WAS 128 MG/DL COMPARED WITH THE SENSOR GLUCOSE READING OF 86 MG/DL. ANOTHER INSTANCE WAS A BLOOD GLUCOSE READING OF 116 MG/DL COMPARED WITH THE SENSOR GLUCOSE READING OF 87 MG/DL. SHE CALLED ANOTHER TIME AND REPORTED THAT THE INSULIN PUMP ALARMED A LOW SENSOR GLUCOSE WARNING WHEN HER SENSOR GLUCOSE READING WAS 69 MG/DL AND HER BLOOD GLUCOSE READING WAS 84 MG/DL. UPON TROUBLESHOOTING, IT WAS FOUND THAT THE CURRENT SENSOR WAS WORKING AS DESIGNED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581659 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A E274U

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR