BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 21027011 · Received December 27, 2024

    Report

    Report Number
    3013756811-2024-239472
    Event Type
    Malfunction
    Date Received
    December 27, 2024
    Date of Event
    December 6, 2024
    Report Date
    March 10, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    DURING FOLLOW UP WITH DISTRIBUTOR BY TECHNICAL SUPPORT ON MARCH 7TH, 2025: THIS EVENT IS A DUPLICATE AND CAPTURED IN MFG REPORT # 3013756811-2024-242050. DURING FOLLOW UP WITH DISTRIBUTOR BY TECHNICAL SUPPORT ON MARCH 7TH, 2025: THIS EVENT IS A DUPLICATE AND CAPTURED IN MFG REPORT # 3013756811-2024-242050.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALFUNCTION ALARM OCCURRED. THE CUSTOMER RESUMED INSULIN DELIVERY, CUSTOMER DOES HAVE MANUAL INJECTION AVAILABLE IF NEEDED FOR INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2511342 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown