BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15217000 · Received August 12, 2022

    Report

    Report Number
    3013756811-2022-84975
    Event Type
    Injury
    Date Received
    August 12, 2022
    Date of Event
    July 20, 2022
    Report Date
    July 20, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 37 MG/DL., DUE TO NEEDING A SETTINGS ADJUSTMENT. REPORTEDLY, PARAMEDICS WERE CALLED AND ASSISTED THE CUSTOMER BY PROVIDING GLUCOSE FOR THEIR BG LEVEL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, SETTINGS WERE UPDATED TO BETTER MEET THE NEEDS OF THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2518306 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention