BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 7192501 · Received January 15, 2018

    Report

    Report Number
    3004753838-2018-005785
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    30386270000157
    PMA / PMN Number
    P120005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COM (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6)2017, THAT ON (B)(6)2017, AN ERROR ICON WAS DISPLAYED ON THE RECEIVER. THE RECEIVER WAS RECEIVED FOR EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS WERE FOUND. A CHARGING AND BOOT UP TEST WAS PERFORMED AND THE RECEIVER FAILED TO BOOT UP. THE REPORTED ISSUE WAS CONFIRMED BECAUSE THE RECEIVER WAS PERPETUALLY REBOOTING. THE PROBABLE CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)94) 2017, THAT ON (B)(6) 2017, AN ERROR ICON WAS DISPLAYED ON THE RECEIVER. DATA WAS NOT 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
    34220 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. MT22495 30386270000157

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR