BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15330075 · Received August 31, 2022

    Report

    Report Number
    3013756811-2022-92794
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    August 12, 2022
    Report Date
    February 14, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM¿S T:SLIM X2 WITH CONTROL-IQ USER GUIDE DESCRIBES HOW TO REMOVE AIR FROM THE CARTRIDGE USING THE SYRINGE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. REPORTEDLY, THE CUSTOMER DID NOT PRACTICE PROPER CARTRIDGE AIR REMOVAL TECHNIQUE. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 251-265 MG/DL. THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2616128 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 60346665

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Female INFUSION SET: TRUSTEEL, INSULIN: NOVOLOG/NOVORAPID