BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 8136185 · Received December 5, 2018

    Report

    Report Number
    3004753838-2018-152106
    Event Type
    Malfunction
    Date Received
    December 5, 2018
    Date of Event
    November 9, 2018
    Report Date
    November 10, 2018
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT EXPERIENCED ADVERSE EVENTS ON DIFFERENT DAYS WITH THE SAME DEVICE. THE FOLLOWING REPORTS ARE BEING SUBMITTED: (B)(4).

    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 RECEIVER INITIALIZED WITHOUT A MANUAL RESTART. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. NO PRODUCT OR DATA WERE PROVIDED FOR EVALUATION. THE REPORT OF THE RECEIVER INITIALIZING WITHOUT MANUAL RESTART COULD NOT BE DETERMINED. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW, THIS RECORD HAS BEEN DETERMINED TO NOT BE REPORTABLE BASED ON CONFIRMATION THAT THIS WAS A DUPLICATE OF A NON-REPORTABLE RECORD. PLEASE DISREGARD INITIAL REPORTING UNDER MFR# 3004753838-2018-152106.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975786 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT20649-1 5224380

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR