BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19884266 · Received August 1, 2024

    Report

    Report Number
    3013756811-2024-133852
    Event Type
    Injury
    Date Received
    August 1, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 1, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM (ER) WITH A BLOOD GLUCOSE (BG) LEVEL RANGING FROM 162-432 MG/DL AND WITH TRACE KETONES. CAUSE WAS NOT KNOWN. PRIOR TO GOING TO THE ER, A CORRECTION BOLUS AND MANUAL INSULIN INJECTION WAS ADMINISTERED TO ADDRESS BG LEVEL. CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN TO ADDRESS THE ELEVATED BG. THE CUSTOMER WAS RELEASED ON (B)(6) 2024 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE. SYSTEM CHECK CONFIRMED THE PUMP WAS FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118870 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INSULIN TYPE: HUMALOGINFUSION SET PRODUCT: AUTOSO