BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7293663 · Received February 23, 2018

    Report

    Report Number
    3004753838-2018-019341
    Event Type
    Malfunction
    Date Received
    February 23, 2018
    Date of Event
    January 18, 2018
    Report Date
    January 26, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180126-001517,180127-000566,180127-000609,180127-000646,180127-000673,180127-000704,180127-000717,180127-000736,180127-000748,180127-000812,180127-000824,180127-000835,180127-000849,180127-000860,180127-000868,180127-000880,180127-000904,180127-000925,180127-000938,180127-000951,180127-000965,180127-000979,180127-001019,180127-001031,180127-001048,180127-001062,180127-001076,180127-001142,180127-001152,180127-001164,180127-001175,180127-001186,180127-001206,180127-001217,180127-001309,180127-001316,180127-001323,180127-001338,180127-001345,180127-001357,180127-001385,180127-001394,180127-001407,180127-001413,180127-001420,180127-001424,180127-001429,180127-001439,180127-001449,180127-001457,180127-001468,180127-001482,180127-001492,180127-001505,180128-000368,180128-000373,180128-000387,180128-000397,180128-000403,180128-000431,180128-000442,180128-000451,180128-000461,180128-000476,180128-000488,180128-000496,180128-000528,180128-000545,180128-000551,180128-000592,180128-000605,180128-000615,180128-000624,180128-000637,180128-000648,180128-000663,180128-000669,180128-000691,180128-000696,180128-000707,180128-000713,180128-000730,180128-000738,180128-000744,180128-000750,180128-000760,180128-000776.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018 THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. DATA WAS RETURNED AND EVALUATED. THE REPORTED EVENT OF A LOSS OF CONNECTION WAS CONFIRMED VIA DATA. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. LABELING INDICATES THAT THE DEXCOM CGM APPLICATION IS ONLY COMPATIBLE FOR SELECT DEVICES AND OPERATING SYSTEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135097 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR