BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7488154 · Received May 4, 2018

    Report

    Report Number
    3004753838-2018-047972
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    March 10, 2018
    Report Date
    April 4, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    UDI-DI
    00386270000002
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS. THE FOLLOWING REPORTS ARE BEING SUBMITTED: 180404-002563,180503-001848,180503-001862,180503-001882,180503-001887,180503-001895,180503-001900,180503-001906,180503-001913,180503-001930,180503-001938,180503-001955,180503-001964,180503-001965,180503-001967,180503-001968,180503-001971,180503-001996,180503-001999,180503-002001,180503-002003,180503-002006,180503-002007,180503-002013,180503-002015,180503-002018,180503-002080,180503-002117,180503-002122,180503-002125,180503-002127,180503-002128,180503-002131,180503-002133,180503-002137,180503-002140,180503-002142,180503-002144,180503-002147.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON 04/04/2018, THAT ON (B)(6) 2018, A LOSS OF CONNECTION OCCURRED. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION OF A LOSS OF CONNECTION COULD NOT BE DETERMINED. A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329909 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. N/A 00386270000002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR