BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8072092 · Received November 14, 2018

    Report

    Report Number
    3004753838-2018-141437
    Event Type
    Malfunction
    Date Received
    November 14, 2018
    Date of Event
    October 10, 2018
    Report Date
    October 16, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P170031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE BASED ON CONFIRMATION THAT A DETACHED SENSOR WIRE DID NOT OCCUR. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2018-141437.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(4) 2018, THAT ON (B)(6) 2018 A DETACHED SENSOR WIRE OCCURRED. THE SENSOR WAS INSERTED INTO THE ABDOMEN ON (B)(6) 2018. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WAS PROVIDED FOR EVALUATION. CONFIRMATION OF THE COMPLAINT COULD NOT BE DETERMINED. THE ROOT CAUSE COULD NOT BE DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908527 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 9500-46 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR