BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12268344 · Received August 3, 2021

    Report

    Report Number
    3013756811-2021-82282
    Event Type
    Injury
    Date Received
    August 3, 2021
    Date of Event
    July 10, 2021
    Report Date
    August 3, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 OF 47 MG/DL. CUSTOMER ALLEGED THAT CONTROL-IQ (CIQ) DELIVERED A BOLUS DURING SLEEP MODE, RESULTING IN LOW BG. SYSTEMS CHECK AND PUMP DATA REVIEW BY TANDEM TECHNICAL SUPPORT SHOWED THAT PUMP AND CIQ WERE FUNCTIONING AS INTENDED AND THAT CUSTOMER HAD MANUALLY DELIVERED THE BOLUS; HOWEVER, CUSTOMER MAINTAINED THAT CIQ WAS NOT FUNCTIONING PROPERLY. LOW BG WAS ADDRESSED BY CONSUMING CARBOHYDRATES, MILK, AND SUGAR PACKS. TANDEM TECHNICAL SUPPORT ADVISED CUSTOMER TO CONSULT THEIR HEALTHCARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164956 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other