BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3974281 · Received August 1, 2014

    Report

    Report Number
    2032227-2014-05303
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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

    THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE LEVEL AT THE TIME OF THE INCIDENT WAS 580 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER EXPERIENCED DRY MOUTH AND SLURRED SPEECH. THE PATIENT WAS TREATED WITH ANTIBIOTICS. THE CURRENT BLOOD GLUCOSE READING WAS 107 MG/DL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449806 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization