BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15545241 · Received October 5, 2022

    Report

    Report Number
    3013756811-2022-108685
    Event Type
    Malfunction
    Date Received
    October 5, 2022
    Date of Event
    September 6, 2022
    Report Date
    November 14, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    ¿ PUMP DECLARED ALARM 20. ¿ CUSTOMER'S BG AT TIME OF EVENT - 140MG/DL ; BETWEEN 54-500 MG/DL (3.0-27.7 MMOL/L), NO FURTHER BG QUESTIONS REQUIRED. ¿ NOTABLE EVENTS THAT LED UP TO THE ALARM. - CUSTOMER STATES THIS CARTRIDGE ALARM HAS BEEN OCCURRING FREQUENTLY ¿ DID EVENT OCCUR DURING LOAD OR PUMPING? - LOAD ¿ WERE THE ON-SCREEN LOAD INSTRUCTIONS FOLLOWED? - YES ¿ DID ALARM RECUR AFTER A SECOND CARTRIDGE WAS LOADED? - YES ¿ RESOLUTION - CTS TO RMA PUMP AND SEND GOODWILL CARTRIDGES. ¿ IS THE CUSTOMER CANADIAN? ¿ NO ¿ IS PUMP SN AVAILABLE? ¿ YES ¿ PUMP SN: 802104 ¿ IS THE PUMP WITHIN WARRANTY? ¿ YES ¿ WARRANTY EXPIRATION DATE: 3/17/2025 ¿ PUMP SW VERSION: 7.4 ¿ IS CALLER¿S WARRANTY START DATE WITHIN THE LAST 30 DAYS? ¿ NO ¿ IS CUSTOMER USING THE T:CONNECT MOBILE APP? ¿ YES ¿ WHAT TYPE OF BACKUP THERAPY WILL CUSTOMER USE TO ENSURE THAT INSULIN DELIVERY IS NOT INTERRUPTED? - CUSTOMER WILL CONTINUE TO USE CURRENT PUMP. ¿ CTS CONFIRMED SHIPPING ADDRESS. ¿ WOULD THE CALLER LIKE A SIGNATURE REQUIRED FOR DELIVERY? ¿ NO ¿ DOES THE CALLER KNOW HOW TO PUT THE PUMP INTO STORAGE MODE? ¿ NO, CTS PROVIDED STORAGE MODE INSTRUCTIONS AND INSTRUCTED CALLER TO PUT PUMP INTO STORAGE MODE PRIOR TO RETURNING IT TO TANDEM. CALLER UNDERSTOOD AND ACKNOWLEDGED. ¿ CTS ADVISED CALLER THAT THEY WILL NEED TO ENTER THEIR PERSONAL PROFILE SETTINGS INTO THEIR REPLACEMENT PUMP. CALLER UNDERSTOOD AND ACKNOWLEDGED. ¿ CTS INSTRUCTED CALLER TO RETURN PROBLEMATIC PUMP TO TANDEM VIA UPS USING RETURN BOX AND PRE-PAID LABEL WITHIN 10 DAYS. CALLER UNDERSTOOD AND ACKNOWLEDGED. ¿ RESOLUTION ¿ CTS SENT REPLACEMENT PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003709 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 42 YR Male