BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8215522 · Received January 3, 2019

    Report

    Report Number
    3004753838-2019-001629
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 15, 2018
    Report Date
    January 3, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    PQF
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    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, AN "HW BBT" ERROR WAS DISPLAYED ON THE RECEIVER. NO PRODUCT OR DATA WAS AVAILABLE FOR EVALUATION. CONFIRMATION OF THE ERROR ICON AND A PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6311 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR PQF DEXCOM, INC. MT22719-PNK 5224431

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR