BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12544302 · Received September 28, 2021

    Report

    Report Number
    3013756811-2021-108348
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    September 1, 2021
    Report Date
    September 28, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT PUMP DID NOT DELIVER AN AUTOMATIC BOLUS WHILE IN CONTROL-IQ (CIQ) SLEEP MODE AS INITIALLY ALLEGED. REPORTEDLY, CUSTOMER HAD MANUALLY SUSPENDED CIQ SLEEP MODE AND AN AUTOMATIC BOLUS WAS DELIVERED DURING THIS PERIOD OF SUSPENSION. AT SOME POINT FOLLOWING THIS BOLUS, CUSTOMER REENABLED CIQ SLEEP MODE.

    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 CONTROL-IQ DELIVERED AN AUTOMATIC BOLUS DESPITE THE PUMP BEING IN SLEEP MODE. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IN THE RANGE OF 70 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435961 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 33 YR