BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 21562082 · Received March 10, 2025

    Report

    Report Number
    3013756811-2025-44131
    Event Type
    Injury
    Date Received
    March 10, 2025
    Date of Event
    February 18, 2025
    Report Date
    March 10, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 46 MG/DL. CAUSE WAS NOT KNOWN. REPORTEDLY, THE CUSTOMER WAS VISITING THEIR PARENT AT THE HOSPITAL WHEN THE LOW BG OCCURRED. MEDICAL STAFF PROVIDED GRAHAM CRACKERS AND APPLE JUICE WITH SUGAR TO ADDRESS BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2144567 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152319810

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Female