BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4233518 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48918
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    September 18, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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 CUSTOMER HAD A BLOOD GLUCOSE LEVEL OF 236 MG/DL WHILE HER SENSOR GLUCOSE READING WAS 89 MG/DL. STANDARD TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED SHE DOES HAVE SOME SCAR TISSUE IN THE AREA SHE USES THE SENSOR. THE CUSTOMER WAS ADVISED TO MONITOR THE SENSOR. THE PRODUCT IS NOT BEING RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712924 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A C214U

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR