BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14642021 · Received June 9, 2022

    Report

    Report Number
    3013756811-2022-60224
    Event Type
    Malfunction
    Date Received
    June 9, 2022
    Date of Event
    May 26, 2022
    Report Date
    May 26, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    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 INFUSION SET EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMER DELIVERED A MANUAL INSULIN INJECTION TO ADDRESS THE ISSUE AND CLEARED THE ALARM. REPORTEDLY, THE CUSTOMER WAS WEARING THE INFUSION SET FOR 3 DAYS AND THE CARTRIDGE FOR 6 DAYS, AND NOT CLEANING THE PNEUMATIC TAP AND PUMP VENTS. CLINICAL SUPPORT INFORMED CUSTOMER THAT WEARING THE INFUSION SET FOR 3 DAYS AND THE CARTRIDGE FOR 6 DAYS, AND NOT CLEANING THE PNEUMATIC TAP AND PUMP VENTS, IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMER'S BLOOD GLUCOSE WAS 181-182 MG/DL..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2156036 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female INFUSION SET: TRUSTEELINSULIN: NOVOLOG / NOVORAPI