BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17867540 · Received October 4, 2023

    Report

    Report Number
    3013756811-2023-139042
    Event Type
    Malfunction
    Date Received
    October 4, 2023
    Date of Event
    September 11, 2023
    Report Date
    October 4, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 200 UNITS OF INSULIN DURING THE LOAD SEQUENCE. CUSTOMER RELOADED THE CARTRIDGE TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT AN O-RING WAS ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE O-RING FROM THE PUMP AND SUCCESSFULLY RELOADED THE EXISTING CARTRIDGE TO RESUME INSULIN THERAPY. LASTLY, IT WAS REPORTED THAT A CARTRIDGE NOT TO FIT SECURELY ONTO THE PUMP. MULTIPLE CONTACT ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE ISSUE; HOWEVER, NO RESPONSE WAS RECEIVED FROM THE CUSTOMER. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 132-138 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200985 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 53 YR Female