BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR ENLITE

    MDR report key: 4062066 · Received September 4, 2014

    Report

    Report Number
    2032227-2014-16307
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 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. SEE MEDWATCH REPORTE # 2032227-2014-16768.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SENSOR READINGS WERE OFF FROM SENSOR GLUCOSE LEVELS. CUSTOMER STATED HER BLOOD GLUCOSE WAS 44 MG/DL AND THE DEVICE DID NOT EVEN ALARM TO WARN HER SHE WAS LOW. CUSTOMER TREATED WITH GLUCOSE TABLETS. TROUBLESHOOTING WAS PERFORMED FOR CALIBRATION AND LOST SENSOR. CUSTOMER WAS ADVISED TO CALIBRATE THE SENSOR WHEN HER BLOOD GLUCOSE WAS STABLE. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542922 SENSOR ENLITE OZO OZO MEDTRONIC MINIMED MMT-7008A HG055MD

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention