BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 10038852 · Received May 8, 2020

    Report

    Report Number
    3013756811-2020-46105
    Event Type
    Malfunction
    Date Received
    May 8, 2020
    Date of Event
    April 17, 2020
    Report Date
    May 8, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM X2 WITH CIQ TECHNOLOGY USER GUIDE STATES: DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR U-100 NOVOLOG. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE VERY HIGH OR A VERY LOW BLOOD GLUCOSE. TECHNICAL SUPPORT INFORMED CUSTOMER THAT IS OFF-LABEL PER THE USER GUIDE. PER TANDEM¿S CARTRIDGE INSTRUCTIONS FOR USE: ¿MAKE SURE THAT INSULIN IS AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE.¿ 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 AN OCCLUSION ALARM OCCURRED. CUSTOMER REPORTED USING APIDRA INSULIN. ADDITIONALLY, CUSTOMER REPORTED USING COLD INSULIN. TANDEM CUSTOMER TECHNICAL SUPPORT INFORMED CUSTOMER THAT APIDRA IS OFF LABEL PER THE USER GUIDE. PER TANDEM¿S CARTRIDGE INSTRUCTIONS FOR USE: ¿MAKE SURE THAT INSULIN IS AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE.¿ CUSTOMER CHANGED TUBING TO ADDRESS THE OCCLUSION ALARMS AND SUCCESSFULLY RESUMED INSULIN. CUSTOMER'S BLOOD GLUCOSE WAS 175 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504108 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR INSULIN: APIDRA, INFUSION SET: AUTOSOFT XC