BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 15287477 · Received August 24, 2022

    Report

    Report Number
    3004753838-2022-155680
    Event Type
    Injury
    Date Received
    August 24, 2022
    Date of Event
    August 1, 2022
    Report Date
    August 24, 2022
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    PMA / PMN Number
    DEN170088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). INITIAL REPORTER EMAIL ADDRESS: (B)(6). DIABETES MELLITUS IS A KNOWN CAUSE OF HYPOGLYCEMIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEDIATRIC PATIENT EXPERIENCED A HYPOGLYCEMIC EVENT. THE SENSOR WAS INSERTED INTO THE ARM ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT LOST THE DEXCOM SENSOR WITHOUT NOTICING DUE TO THE POOR PATCH ADHESION, AND THE PARENT INDICATED THAT THEREFORE THE T-SLIM INSULIN PUMP DID NOT RECEIVE ANY INFORMATION AND KEPT RELEASING INSULIN. ABOUT FIVE MINUTES AFTER EVENTUALLY NOTICING THE PATCH ISSUE THE PATIENT BECAME SYMPTOMATIC FOR HYPOGLYCEMIA, BECAME SHORT OF BREATH, AND HAD A SEIZURE. NO BLOOD GLUCOSE (BG) VALUE AT THIS TIME WAS REPORTED AND IT IS UNKNOWN WHAT THE INSULIN PUMP WAS DISPLAYING. THE PATIENT'S MOTHER TREATED THE PATIENT WITH BAQSIMI (GLUCAGON NASAL POWDER) AND PROVIDED UNSPECIFIED FIRST AID TO THE PATIENT WHILE THE EMERGENCY PERSONNEL WAS ARRIVING. THE BG WAS 70 MG/DL AFTER THE FIRST AID TREATMENT. THE EMERGENCY PERSONNEL TOOK THE PATIENT TO THE HOSPITAL AND HE WAS HOSPITALIZED FOR SEVEN DAYS. NO INFORMATION WAS DOCUMENTED ABOUT THE TREATMENT PROVIDED DURING THE HOSPITALIZATION. THE PATIENT RECOVERED AND AT THE TIME OF THE REPORT WAS DOING FINE. NO PRODUCT WAS PROVIDED FOR EVALUATION. THE COMPLAINT CONFIRMATION WAS UNABLE TO BE DETERMINED. THE PROBABLE CAUSE WAS NOT DETERMINED. NO ADDITIONAL PATIENT OR EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439765 DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other| H