BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11345285 · Received February 18, 2021

    Report

    Report Number
    3013756811-2021-20420
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    January 28, 2021
    Report Date
    February 18, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613380
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL BELOW 50 MG/DL DUE TO NEEDING SETTINGS ADJUSTMENTS. LOW BG WAS ADDRESSED BY CONSUMING CARBOHYDRATES. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, SETTINGS WERE UPDATED TO MATCH CUSTOMER'S HEALTHCARE PROVIDER'S RECOMMENDATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241296 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613380

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other