BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4242961 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50487
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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

    CUSTOMER REPORTED THAT THE SENSOR READINGS WERE INACCURATE. CUSTOMER REPORTED THAT HE RECEIVED A MESSAGE SAYING THAT HIS BLOOD GLUCOSE LEVEL WAS DROPPING WHEN IT WAS ACTUALLY RISING. CUSTOMER REPORTED THAT EARLIER IN THE DAY OF THE CALL, HIS BLOOD GLUCOSE LEVEL WAS 105 MG/DL AND HIS SENSOR GLUCOSE LEVEL WAS 55 MG/DL. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS 190 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727425 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG04LNQ

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR