BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16772940 · Received April 19, 2023

    Report

    Report Number
    3013756811-2023-53275
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 27, 2023
    Report Date
    April 19, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. USE ERROR/AIR REMOVAL THE TANDEM PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. USE ERROR/COLD INSULIN THE CARTRIDGE USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING A CARTRIDGE. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. REPORTEDLY, THE CUSTOMER WAS NOT REMOVING AIR FROM THE CARTRIDGE DURING THE LOAD SEQUENCE, AND THAT THE CUSTOMER LOADED COLD INSULIN INTO THE CARTRIDGE. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER THAT THIS IS OFF LABEL. CUSTOMER RELOADED THE CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200-346 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1547588 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female