BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8723760 · Received June 21, 2019

    Report

    Report Number
    3013756811-2019-34426
    Event Type
    Malfunction
    Date Received
    June 21, 2019
    Date of Event
    May 30, 2019
    Report Date
    June 21, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: KEEP THE TRANSMITTER AND THE PUMP WITHIN 20 FEET OF EACH OTHER WITHOUT OBSTRUCTION. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSMITTER LOST CONNECTION WITH THE PUMP FOR OVER ONE HOUR. REPORTEDLY, THE TRANSMITTER WAS NOT BEING WORN WITHIN LINE OF SIGHT OF THE PUMP. THE CUSTOMER MOVED THE PUMP AND TRANSMITTER WITHIN LINE OF SIGHT AND CONNECTION RESUMED. NO ADDITIONAL PATIENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518449 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR