BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15896292 · Received December 1, 2022

    Report

    Report Number
    3013756811-2022-139024
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    November 9, 2022
    Report Date
    December 1, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THE CARTRIDGE USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE. PER TANDEM USER GUIDE: ENSURE YOU FIRST FILL SYRINGE WITH INSULIN BEFORE REMOVING AIR FROM CARTRIDGE. REMOVING EXCESS AIR CAN AFFECT PRESSURIZATION AND AFFECT HOW THE PUMP DELIVERS INSULIN. PER TANDEM¿S USER GUIDE ¿THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0ML) OF INSULIN.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER WAS USING COLD INSULIN, WAS OVERFILLING THE CARTRIDGE, AND WAS PERFORMING THE CARTRIDGE FILL PROCESS INCORRECTLY. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER ON CARTRIDGE/INSULIN LABELING AND PROPER LOAD TECHNIQUE. ADDITIONALLY, IT WAS REPORTED THAT THE INSULIN GAUGE WAS INCORRECT. CUSTOMERS BLOOD GLUCOSE RANGED FROM 240-360 MG/DL. THE CUSTOMER LOADED NEW PUMP SUPPLIES TO RESOLVE THE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123565 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 61 YR Male