BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 9152560 · Received October 3, 2019

    Report

    Report Number
    3013756811-2019-68551
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    September 9, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    P120005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE TANDEM USER GUIDE: YOU MUST ENTER YOUR TRANSMITTER ID CORRECTLY INTO YOUR PUMP TO RECEIVE SENSOR GLUCOSE READINGS. PER TANDEM'S USER GUIDE, "THE CARTRIDGE IS INDICATED AS A RESERVOIR FOR THE DELIVERY OF RAPID-ACTING INSULIN WITH THE T:SLIM PUMP. HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC. AND FOUND TO BE SAFE FOR USE IN THE T:SLIM PUMP. HUMALOG WAS TESTED FOR UP TO 48 HOURS AS LABELED, NOVOLOG WAS TESTED FOR UP TO 72 HOURS. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED INTERMITTENT INVALID TRANSMITTER ID ALERTS. DESPITE MULTIPLE ATTEMPTS, A SENSOR SESSION WAS UNABLE TO BE STARTED. CUSTOMER REPORTED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 908 MG/DL AND BECAME HOSPITALIZED. THE CUSTOMER BELIEVED THAT THE DEXCOM CONTINUOUS GLUCOSE MONITORING SYSTEM WAS THE CAUSE AS THE CUSTOMER¿S BLOOD GLUCOSE LEVEL BECAME ELEVATED AND THE CUSTOMER SUBSEQUENTLY RECEIVED AN INVALID TRANSMITTER ID ALERT. THE CUSTOMER ARRIVED AT THE HOSPITAL ON (B)(6) 2019. IN AN ATTEMPT TO RESOLVE ELEVATED BG, THE CUSTOMER ADMINISTERED MANUAL INJECTIONS. WHILE AT THE HOSPITAL, THE CUSTOMER WAS TREATED WITH INSULIN DRIP. THE CUSTOMER WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2019 WITH NO PERMANENT DAMAGE AND ISSUE RESOLVED. REPORTEDLY, THE CUSTOMER HAD ENTERED THE INCORRECT TRANSMITTER ID INTO HIS PUMP. ADDITIONALLY, THE CUSTOMER HAD ALSO USED THE SAME CARTRIDGE, INFUSION SET, AND INSULIN FOR MORE THAN 3 DAYS. CTS EDUCATED CUSTOMER THAT THEY MUST ENTER THE CORRECT TRANSMITTER ID INTO THEIR PUMP, AND NOT TO USE THE SAME SUPPLIES FOR MORE THAN 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946065 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R