BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16655509 · Received March 31, 2023

    Report

    Report Number
    3013756811-2023-46378
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    September 1, 2022
    Report Date
    March 31, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. PER TANDEM USER GUIDE: CHANGE YOUR CARTRIDGE EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. PER TANDEM USER GUIDE: WHEN CLEANING YOUR PUMP, USE A DAMP LINT-FREE CLOTH. DO NOT USE HOUSEHOLD OR INDUSTRIAL CLEANERS, SOLVENTS, BLEACH, SCOURING PADS, CHEMICALS, OR SHARP INSTRUMENTS. NEVER SUBMERGE THE PUMP IN WATER OR USE ANY OTHER LIQUID TO CLEAN IT. DO NOT PLACE THE PUMP IN THE DISHWASHER OR USE HOT WATER TO CLEAN IT. IF NEEDED, USE ONLY A VERY MILD DETERGENT, SUCH AS A BIT OF LIQUID SOAP WITH WARM WATER. WHEN DRYING YOUR PUMP, USE A SOFT TOWEL; NEVER PLACE YOUR PUMP IN A MICROWAVE OVEN OR BAKING OVEN TO DRY IT. PER TANDEM USER GUIDE: ALWAYS REMOVE ALL AIR BUBBLES FROM THE CARTRIDGE BEFORE BEGINNING INSULIN DELIVERY. ENSURE THERE ARE NO AIR BUBBLES WHEN DRAWING INSULIN INTO THE FILLING SYRINGE, HOLD THE PUMP WITH THE WHITE FILL PORT POINTED UP WHEN FILLING THE TUBING, AND ENSURE THAT THERE ARE NO AIR BUBBLES IN THE TUBING WHEN FILLING. AIR IN THE SYSTEM TAKES SPACE WHERE INSULIN SHOULD BE AND CAN AFFECT INSULIN DELIVERY. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS STARTED WITH TANDEM TECHNICAL SUPPORT (TTS), HOWEVER, CUSTOMER DECLINED TO COMPLETE THE CHECK. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY THE CUSTOMER IS NOT REMOVING CARTRIDGE AIR, WEARING THE CARTRIDGE FOR 6-8 DAYS, AND NOT CLEANING THE PUMP PNEUMATIC TAP OR PUMP VENTS. TANDEM CLINICAL SUPPORT INFORMED CUSTOMER THAT NOT REMOVING CARTRIDGE AIR, WEARING THE CARTRIDGE FOR 6-8 DAYS, AND NOT CLEANING THE PUMP PNEUMATIC TAP OR PUMP VENTS, IS OFF LABEL PER THE USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 203-228 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581120 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 35 YR Female INFUSION SET: TRUESTEELINSULIN TYPE: NOVOLOG/ NOV