BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17020725 · Received May 30, 2023

    Report

    Report Number
    3013756811-2023-71892
    Event Type
    Malfunction
    Date Received
    May 30, 2023
    Date of Event
    May 8, 2023
    Report Date
    May 30, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000084
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING BASAL DELIVERY. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 180-219 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651069 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00389152000084

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male