BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14564614 · Received June 1, 2022

    Report

    Report Number
    3013756811-2022-52509
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    May 2, 2022
    Report Date
    May 9, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007257
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER TANDEM USER GUIDE: CHANGE YOUR INFUSION SET EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER CHANGE YOUR CARTRIDGE EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. 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 NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER WAS USING SUPPLIES BEYOND LABELING AND WAS NOT PERFORMING THE AIR REMOVAL PROCESS CORRECTLY. TANDEM TECHNICAL SUPPORT PROVIDED PROPER SUPPLIES LABELING AS WELL AS EDUCATED THE CUSTOMER ON THE PROPER AIR REMOVAL PROCESS. THE CUSTOMER REPLACED THE PUMP SUPPLIES AND RESUMED INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE WAS IN THE RANGE OF 132-352 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1599464 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female INFUSION SET: TRUSTEELINSULIN: NOVOLOG