BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 8200737 · Received December 27, 2018

    Report

    Report Number
    3004753838-2018-162967
    Event Type
    Injury
    Date Received
    December 27, 2018
    Date of Event
    November 24, 2018
    Report Date
    November 28, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR ADVERSE EVENT IS BEING REPORTED UNDER MFR 3004753838-2018-162965.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THE PATIENT EXPERIENCED A HYPOGLYCEMIC EPISODE. IT IS UNCLEAR IF THE DEXCOM SYSTEM CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT¿S HUSBAND STATED THAT THE PATIENT¿S ENDOCRINOLOGISTS NEEDS THE PATIENT¿S GLUCOSE READINGS. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039332 NI CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other