BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE MMT-7008A

    MDR report key: 4150366 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-35075
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    August 16, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    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

    IT IS REPORTED THAT THE PATIENT EXPERIENCED A HIGH BLOOD GLUCOSE LEVEL. LEVEL AT THE TIME WAS 535MG/DL. TROUBLE SHOOTING WAS CONDUCTED AND WE EXPLAINED THE POSSIBLE REASONS FOR A HIGH BLOOD GLUCOSE LEVEL TO THE PATIENT. THE DEVICE IS NOT BEING RETURNED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629330 SENSOR ENLITE MMT-7008A OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR