BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10733675 · Received October 26, 2020

    Report

    Report Number
    3013756811-2020-118733
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    January 12, 2019
    Report Date
    October 26, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: DO NOT REMOVE OR ADD INSULIN FROM A FILLED CARTRIDGE AFTER LOADING ONTO THE PUMP. THIS WILL RESULT IN AN INACCURATE DISPLAY OF THE INSULIN LEVEL ON THE HOME SCREEN AND YOU COULD RUN OUT OF INSULIN BEFORE THE PUMP DETECTS AN EMPTY CARTRIDGE. THIS CAN CAUSE VERY HIGH BLOOD GLUCOSE, OR DIABETIC KETOACIDOSIS (DKA). 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. DURING SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT, IT WAS IDENTIFIED CUSTOMER WAS FILLING CARTRIDGES ON THE PUMP AND OVERFILLING CARTRIDGES. TECHNICAL SUPPORT INSTRUCTED CUSTOMER NOT TO ADD INSULIN TO THE CARTRIDGE AFTER LOADING ONTO THE PUMP PER THE USER GUIDE. CUSTOMER CLEARED THE ALARM OR CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 100-310 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200266 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INFUSION SET: AUTOSOFT 90INSULIN: NOVOLOG/NOVORAP