BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4032978 · Received August 25, 2014

    Report

    Report Number
    2032227-2014-11009
    Event Type
    Malfunction
    Date Received
    August 25, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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 IS REPORTING ISSUES WITH BLOOD GLUCOSE VERSUS SENSOR GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 160 MG/DL. CUSTOMER DECLINED TO TROUBLESHOOT AS SHE STATES SHE HAS DONE THAT BEFORE AND SHE WAS ADVISED BY HER HEALTH CARE PROVIDER THAT THERE WAS SOMETHING WRONG WITH THE TRANSMITTER. CUSTOMER WAS TRANSFERRED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513097 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR