BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18184912 · Received November 21, 2023

    Report

    Report Number
    3013756811-2023-161267
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    October 17, 2023
    Report Date
    January 8, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SPEAKER AND VIBRATOR ISSUE WAS NOT VERIFIED. LOW BG ISSUES THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED OCCLUSION ISSUE WAS VERIFIED, HOWEVER, NO FAILURE WAS IDENTIFIED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP'S ALARM SOUND WAS NOT ANNUNCIATING. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS "HIGH"; ALTHOUGH SPECIFIC VALUE WAS NOT PROVIDED. A CORRECTION BOLUS WAS DELIVERED TO ADDRESS BG. ADDITIONALLY, IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 200-437 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1925558 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613793

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male INSULIN: NOVOLOGINFUSION SET: AUTOSOFT 90