BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18184281 · Received November 21, 2023

    Report

    Report Number
    3013756811-2023-167256
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    November 2, 2023
    Report Date
    February 6, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000077
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED ISSUE COULD NOT BE VERIFIED; HOWEVER, A DIFFERENT ISSUE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE PUMP FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS RANGED FROM 180-270 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1577799 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000077

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female