BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15890517 · Received November 30, 2022

    Report

    Report Number
    3013756811-2022-136385
    Event Type
    Injury
    Date Received
    November 30, 2022
    Date of Event
    October 28, 2022
    Report Date
    November 30, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMIITENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT (TTS) AND NO ISSUES WERE IDENTIFIED. CUSTOMER CHANGED THE PUMP SUPPLIES AND SUCCESSFULLY RESUMED INSULIN THERAPY. REPORTEDLY, THE CUSTOMER WAS REMOVING THE AIR FROM THE CARTRIDGE SEVERAL TIMES. TANDEM CLINICAL SUPPORT INFORMED CUSTOMER THAT REMOVING THE AIR FROM THE CARTRIDGE SEVERAL TIMES, IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 200-543 MG/DL. ELEVATED BLOOD GLUCOSE LEVELS WERE ADDRESSED BY MANUAL INSULIN INJECTION AND CHANGING THE INFUSION SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2664418 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 55 YR Female Other INFUSION SET: TRUSTEELINSULIN: HUMALOG