BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15396635 · Received September 9, 2022

    Report

    Report Number
    3013756811-2022-97235
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 20, 2022
    Report Date
    August 20, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 120 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A CARTRIDGE WAS RELOADED TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. A SYSTEM CHECK WAS PERFORMED, AND THE OCCLUSION WAS FOUND TO BE WITHIN THE CARTRIDGE. A CARTRIDGE CHANGE CHANGE WAS PERFORMED RESOLVING THE OCCLUSION. IT WAS ALSO REPORTED THAT AN UNEXPECTED RESET OCCURRED. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS IN 172-298 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361244 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male INSULIN TYPE: NOVOLOG/NOVORAPID