BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16961810 · Received May 19, 2023

    Report

    Report Number
    3013756811-2023-70795
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 16, 2023
    Report Date
    July 13, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. PER TANDEM USER GUIDE: ONLY USE U-100 HUMALOG OR U-100 NOVOLOG WITH YOUR PUMP. ONLY U-100 HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE PUMP. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE HYPOGLYCEMIA (LOW BG) OR HYPERGLYCEMIA (HIGH BG) EVENTS. PER TANDEM USER GUIDE: AVOID EXPOSURE OF YOUR PUMP TO TEMPERATURES BELOW 40°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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY THE CUSTOMER IS USING APIDRA INSULIN., AND USING COLD INSULIN. TANDEM TECHNICAL SUPPORT (CTS) INFORMED CUSTOMER THAT USING APIDRA INSULIN, AND COLD INSULIN, IS OFF LABEL PER THE USER GUIDE. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY, AND CUSTOMER HAS MANUAL INSULIN INJECTIONS IF NEEDED. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 250-460 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1017304 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0740114 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female INFUSION SET: AUTOSOFT 30INSULIN TYPE: APIDRA