BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17352070 · Received July 19, 2023

    Report

    Report Number
    3013756811-2023-100819
    Event Type
    Malfunction
    Date Received
    July 19, 2023
    Date of Event
    June 28, 2023
    Report Date
    July 19, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152000091
    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. 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 147 UNITS OF INSULIN DURING THE LOAD SEQUENCE. ADDITIONALLY, IT WAS REPORTED THAT INSULIN DRIPS WERE NOT OBSERVED TO BE EXITING THE TUBING DURING THE LOAD FILL PROCESS. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL RANGED FROM 132-163 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025162 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60442907 00389152000091

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male INFUSION SET: AUTOSOFT XCINSULIN: HUMALOG