BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19559161 · Received June 18, 2024

    Report

    Report Number
    3013756811-2024-108083
    Event Type
    Injury
    Date Received
    June 18, 2024
    Date of Event
    May 10, 2024
    Report Date
    July 26, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Additional Manufacturer Narrative · 0

    D9, H3, H10, REMOVE MDR CODES 11, 3233, 4118. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. D9, H3, H10, REMOVE MDR CODES 11, 3233, 4118. 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 PUMP BATTERY WAS DEPLETING QUICKLY RESULTING IN THE PUMP SHUTTING OFF. THE CUSTOMERS BLOOD GLUCOSE (BG) WAS ¿HIGH¿; HOWEVER, A SPECIFIC VALUE WAS NOT PROVIDED. REPORTEDLY THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS BG. TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT INDICATED THAT PUMP BATTERY WAS DEPLETING NORMALLY BASED ON SETTINGS AND CUSTOMER USAGE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322245 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female