BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16311884 · Received February 7, 2023

    Report

    Report Number
    3013756811-2023-19894
    Event Type
    Injury
    Date Received
    February 7, 2023
    Date of Event
    January 16, 2023
    Report Date
    April 11, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613793
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED ISSUE COULD NOT BE VERIFIED; HOWEVER, A USER PARAMETERS CORRUPTED ALERT WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. CUSTOMER CONFIRMED PUMP DISPLAY TURNED ON WHEN PLUGGED INTO A POWER SOURCE. CUSTOMER¿S BLOOD GLUCOSE (BG) LEVEL WAS 240 - 438 MG/DL, WITH VOMITING. REPORTEDLY, THE CUSTOMER ADDRESSED THEIR BG WITH A MANUAL DOSE INJECTION AND REQUIRED ASSISTANCE TO ADMINISTER A CORRECTION BOLUS VIA THE PUMP. CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1495090 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 73 YR Male Required Intervention INSULIN TYPE: HUMALOG