BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11003761 · Received December 14, 2020

    Report

    Report Number
    3013756811-2020-140888
    Event Type
    Malfunction
    Date Received
    December 14, 2020
    Date of Event
    November 21, 2020
    Report Date
    December 14, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: CHANGE YOUR INFUSION SET EVERY 48 TO 72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER REPORTED USING TRUSTEEL INFUSION SETS FOR 3 DAYS. TANDEM TECHNICAL SUPPORT INFORMED CUSTOMER THAT TRUSTEEL INFUSION SETS SHOULD BE CHANGED EVERY 48 HOURS PER THE USER GUIDE. SYSTEM CHECK WAS STARTED WITH TECHNICAL SUPPORT; HOWEVER, CUSTOMER WAS UNABLE TO COMPLETE THE CHECK AT TIME OF CALL. UPON FOLLOW UP, CUSTOMER REPORTED THEY HAD BEGUN CHANGING PUMP SUPPLIES EVERY 2 DAYS AND THE OCCLUSION HAD NOT RECURRED. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 200-370 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1468120 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR INFUSION SET: TRUSTEEL