BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7118767 · Received December 14, 2017

    Report

    Report Number
    3007981285-2017-38964
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    November 30, 2017
    Report Date
    December 14, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    T:SLIM X2 USER GUIDE STATES, "ALWAYS MAKE SURE THAT THE CORRECT TIME AND DATE ARE SET ON YOUR PUMP. WHEN EDITING TIME, ALWAYS CHECK THAT THE AM/PM SETTING IS ACCURATE. NOT HAVING THE CORRECT TIME AND DATE SETTING MAY AFFECT SAFE INSULIN DELIVERY." THE T:SLIM X2 USER GUIDE STATES, ¿THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0 ML) OF INSULIN¿. THE T:SLIM X2 USER GUIDE STATES, "REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG". 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 THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS IN THE 211-215 MG/DL RANGE. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, IT WAS NOTED THAT THERE WAS AN AIR BUBBLE PRESENT IN THE INFUSION SET TUBING. THE CUSTOMER USES HUMALOG INSULIN, AND REPORTED THE CARTRIDGE AND INFUSION SET ARE TYPICALLY IN USE FOR APPROXIMATELY 5 DAYS AT A TIME. IN ADDITION, THE CUSTOMER PREVIOUSLY INTENTIONALLY OVERFILLED THE CARTRIDGE WITH APPROXIMATELY 320 UNITS OF INSULIN. DURING TROUBLESHOOTING, IT WAS ALSO NOTED THAT THE PUMP TIME WAS INACCURATE, AND THE CUSTOMER DID NOT HAVE TO CORRECT SETTINGS PROFILE TURNED ON. CUSTOMER REPORTED THE TIME WAS INACCURATE DUE TO USE ERROR. A NEW CARTRIDGE WAS LOADED ONTO THE PUMP WITH THE PROPER LOADING PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    898890 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 M020465

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR