BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18336564 · Received December 15, 2023

    Report

    Report Number
    3013756811-2023-178082
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 24, 2023
    Report Date
    December 15, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN O-RING WAS ON THE PNEUMATIC TAP AND THAT A CARTRIDGE CHANGE ERROR OCCURRED. 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 ISSUES. FURTHERMORE, IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED INDICATING THAT THE CARTRIDGE WAS OVER-FILLED DESPITE THE CUSTOMER FILLING THE CARTRIDGE WITH 260 - 270 UNITS OF INSULIN. THE CUSTOMER RE-LOADED THE CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 103 - 126 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1052785 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male