BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16643463 · Received March 30, 2023

    Report

    Report Number
    3013756811-2023-42678
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    March 5, 2023
    Report Date
    April 17, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. PER TANDEM'S USER GUIDE: THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0 ML) OF INSULIN. PER TANDEM USER GUIDE: USE ONLY SINGLE-USE, DISPOSABLE T:SLIM CARTRIDGES. THE EFFICACY OF YOUR T:SLIM PUMP CANNOT BE GUARANTEED IF CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. ARE USED OR IF CARTRIDGES ARE FILLED MORE THAN ONCE. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER-INFUSION OR UNDER-INFUSION AND MAY CAUSE SERIOUS INJURY OR DEATH.

    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. IN ADDITION, REPORTEDLY, THE CUSTOMER OVERFILLED THE CARTRIDGE AND REFILLED THE CARTRIDGE, CAUSING THE INSULIN GAUGE TO BE INACCURATE. A NEW CARTRIDGE WAS LOADED TO RESOLVE BOTH ISSUES. THERE WAS NO ADVERSE IMPACT ON CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571055 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60404389 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female INSULIN: ADMELOG