BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7654293 · Received July 2, 2018

    Report

    Report Number
    3004753838-2018-071141
    Event Type
    Malfunction
    Date Received
    July 2, 2018
    Date of Event
    June 5, 2018
    Report Date
    June 5, 2018
    Manufacturer
    PQF
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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, THERE WAS AN INACCURACY BETWEEN THE CONTINUOUS GLUCOSE MONITOR (CGM) AND THE BLOOD GLUCOSE (BG) METER. DATA WAS RECEIVED FOR EVALUATION, DATA REVIEW CONFIRMED THE REPORTED EVENT OF INACCURATE CGM VALUES. A PROBABLE CAUSE COULD NOT BE DETERMINED VIA DATA. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497686 DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS PQF 9500-27 ASKU 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR