BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 14713571 · Received June 16, 2022

    Report

    Report Number
    3013756811-2022-60919
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 25, 2022
    Report Date
    May 25, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER TANDEM USER GUIDE: THE PUMP USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE. WHEN CLEANING YOUR PUMP, USE A DAMP LINT-FREE CLOTH. DO NOT USE HOUSEHOLD OR INDUSTRIAL CLEANERS, SOLVENTS, BLEACH, SCOURING PADS, CHEMICALS, OR SHARP INSTRUMENTS. NEVER SUBMERGE THE PUMP IN WATER OR USE ANY OTHER LIQUID TO CLEAN IT. DO NOT PLACE THE PUMP IN THE DISHWASHER OR USE HOT WATER TO CLEAN IT. IF NEEDED, USE ONLY A VERY MILD DETERGENT, SUCH AS A BIT OF LIQUID SOAP WITH WARM WATER. WHEN DRYING YOUR PUMP, USE A SOFT TOWEL; NEVER PLACE YOUR PUMP IN A MICROWAVE OVEN OR BAKING OVEN TO DRY IT. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER WAS USING COLD INSULIN AS WELL AS NOT CLEANING THE PNEUMATIC TAP AREA OF THE PUMP. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON INSULIN LABELING AS WELL AS PROPER PNEUMATIC TAP CLEANING TECHNIQUES. THE CUSTOMER CLEARED THE ALARM AND RESUMED INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE WAS 345 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131504 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female INFUSION SET: TRUSTEELINSULIN: NOVOLOG