BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF

    MDR report key: 7378098 · Received March 28, 2018

    Report

    Report Number
    3004753838-2018-31234
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Date of Event
    February 28, 2018
    Report Date
    February 28, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018, THE PATIENT EXPERIENCED A LOSS OF CONNECTION. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. DATA WAS PROVIDED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221766 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM PQF CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR