BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 6149490 · Received December 6, 2016

    Report

    Report Number
    3004753838-2016-52921
    Event Type
    Injury
    Date Received
    December 6, 2016
    Date of Event
    November 7, 2016
    Report Date
    November 14, 2016
    Manufacturer
    DEXCOM, INC.
    Product Code
    MDS
    UDI-DI
    00386270000019
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DEXCOM WAS MADE AWARE ON (B)(6) 2016 THAT ON (B)(6) 2016, THE PATIENT EXPERIENCED CONTINUOUS GLUCOSE MONITORING (CGM) INACCURACIES AND A HYPOGLYCEMIC EVENT. THE SENSOR WAS INSERTED AT THE ABDOMEN ON (B)(6) 2016. PATIENT REPORTED THAT SHE WAS FEELING A LOW AT AROUND 7:00 - 7:30 PM. PATIENT DID A FINGER STICK (FS) AND HER BLOOD GLUCOSE (BG) WAS AT 67 MG/DL, WHILE THE CGM SHOWED 181 MG/DL. EMERGENCY MEDICAL TECHNICIANS (EMTS) WERE CALLED AS THE PATIENT WAS "CRASHING" AND HER BG WAS AT "AROUND 50." PATIENT ATE ¼ GALLON OF ICE CREAM, 1 CUP OF MILK, AND MAYBE 1 CUP OF SODA. PATIENT'S BG RAISED TO 87 MG/DL BY THE TIME EMTS ARRIVED. PATIENT'S BG THEN RAISED TO 190 MG/DL. PATIENT REPORTED THAT THE EMTS DID NOT PROVIDE ANY ASSISTANCE. PATIENT DECLINED TO BE TAKEN TO HOSPITAL. AT THE TIME OF CONTACT PATIENT WAS STABLE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799837 DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR MDS DEXCOM, INC. 9500-27 5216065 00386270000019

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other