BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SENSOR ENLITE

    MDR report key: 3801020 · Received May 8, 2014

    Report

    Report Number
    2032227-2014-01807
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 MEDICAL DEVICE REPORT #: 3004209178-2014-84286.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 20 MG/DL. CUSTOMER STATED THAT THE SENSOR GLUCOSE AND BLOOD GLUCOSE ARE OFF. DURING TROUBLESHOOTING, OFFERED TO MAIL COURTESY SENSORS TO REPLACE WHAT CUSTOMER WASTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277677 SENSOR ENLITE CGM MDS MEDTRONIC MINIMED MMT-7008A

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization