BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 11628535 · Received April 7, 2021

    Report

    Report Number
    3013756811-2021-38375
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    March 13, 2021
    Report Date
    April 7, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 32 MG/DL. LOW BG CAUSE WAS NOT KNOWN. THE CUSTOMER'S PARENT ADMINISTERED A GLUCOSE SHOT AND THE CUSTOMER CONSUMED FROSTING TO ADDRESS BG. EMERGENCY MEDICAL TECHNICIANS (EMTS) ADMINISTERED AN INTRAVENOUS BAG OF D-10 TO TREAT THE LOW BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527121 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention