BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 8956696 · Received September 3, 2019

    Report

    Report Number
    3013756811-2019-55224
    Event Type
    Malfunction
    Date Received
    September 3, 2019
    Date of Event
    August 9, 2019
    Report Date
    September 3, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007981
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM X2 G5 USER GUIDE STATES: DO NOT START TO USE YOUR SYSTEM BEFORE CONSULTING WITH YOUR HEALTHCARE PROVIDER TO DETERMINE WHICH FEATURES ARE MOST APPROPRIATE FOR YOU. ONLY YOUR HEALTHCARE PROVIDER CAN DETERMINE AND HELP YOU ADJUST YOUR BASAL RATE(S), CARB RATIO(S), CORRECTION FACTOR(S), TARGET BG, AND DURATION OF INSULIN ACTION. INCORRECT SETTINGS CAN RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. 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 · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD INPUT SETTINGS INTO THE NEW PUMP. CUSTOMER ALLEGED THAT THE PUMP CALCULATED AN INACCURATE BOLUS DOSAGE. TANDEM TECHNICAL SUPPORT REVIEWED PUMP SETTINGS AND CONFIRMED THAT CUSTOMER HAD INCORRECTLY INPUT CARB RATIO AS 1U:1.8G INSTEAD OF 1U:8G. CUSTOMER CORRECTED THE SETTINGS TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 140-235 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749924 T:SLIM X2 INSULIN PUMP PUMP, INFUSION, INSULIN, TO BE USED WITH INVASIVE GLUCOSE SENSOR OYC TANDEM DIABETES CARE 1000096 00853052007981

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR