BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 18336172 · Received December 15, 2023

    Report

    Report Number
    3013756811-2023-174819
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 24, 2023
    Report Date
    December 15, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613786
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED ISSUE COULD NOT BE VERIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER'S BG VALUE DISPLAYED AS 'LOW' ON THE CONTINUOUS GLUCOSE MONITOR (CGM). THE CAUSE OF LOW BG WAS UNKNOWN. THE CUSTOMER CONSUMED A 12-OUCE SODA, SOME CRANBERRY SAUCE, AND SOME CASSEROLE TO ADDRESS BG. THE CUSTOMER ALSO REPORTED THAT THEY WERE IN SEVERE PAIN BECAUSE OF THE LOW BG. RECOMMENDATION WAS MADE TO CONSULT WITH A HEALTHCARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276061 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613786

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female