BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14110653 · Received April 14, 2022

    Report

    Report Number
    3013756811-2022-39566
    Event Type
    Malfunction
    Date Received
    April 14, 2022
    Date of Event
    March 18, 2022
    Report Date
    March 25, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. PER TANDEM USER GUIDE: ALWAYS REMOVE ALL AIR BUBBLES FROM THE CARTRIDGE BEFORE BEGINNING INSULIN DELIVERY. ENSURE THERE ARE NO AIR BUBBLES WHEN DRAWING INSULIN INTO THE FILLING SYRINGE, HOLD THE PUMP WITH THE WHITE FILL PORT POINTED UP WHEN FILLING THE TUBING, AND ENSURE THAT THERE ARE NO AIR BUBBLES IN THE TUBING WHEN FILLING. AIR IN THE SYSTEM TAKES SPACE WHERE INSULIN SHOULD BE AND CAN AFFECT INSULIN DELIVERY. PER TANDEM USER GUIDE: AVOID EXPOSURE OF YOUR PUMP TO TEMPERATURES BELOW 41°F (5°C) OR ABOVE 99°F (37°C). INSULIN CAN FREEZE AT LOW TEMPERATURES OR DEGRADE AT HIGH TEMPERATURES. INSULIN THAT HAS BEEN EXPOSED TO CONDITIONS OUTSIDE OF THE MANUFACTURER¿S RECOMMENDED RANGES CAN AFFECT THE SAFETY AND PERFORMANCE OF THE PUMP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY, THE CUSTOMER IS REMOVING CARTRIDGE AIR BUBBLES BY DRAWING 250 UNITS, INSERTING NEEDLE INTO CARTRIDGE, PULLING UP ON PLUNGER TO PULL OUT AIR SEVERAL TIMES, REMOVING NEEDLE AND REMOVING AIR, THEN PUTTING BACK INTO CARTRIDGE, AND USING COLD INSULIN. CLINICAL SUPPORT ADVISED CUSTOMER THAT REMOVING CARTRIDGE AIR BUBBLES BY DRAWING 250 UNITS, INSERTING NEEDLE INTO CARTRIDGE, PULLING UP ON PLUNGER TO PULL OUT AIR SEVERAL TIMES, REMOVING NEEDLE AND REMOVING AIR, THEN PUTTING BACK INTO CARTRIDGE, AND USING COLD INSULIN, IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 250-259 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133454 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG