BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 16903919 · Received May 10, 2023

    Report

    Report Number
    3013756811-2023-64114
    Event Type
    Injury
    Date Received
    May 10, 2023
    Date of Event
    April 17, 2023
    Report Date
    May 10, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED ¿ THE WHITE RUBBER CAP POPPED OFF MY T-SLIM RESERVOIR TONIGHT DURING A REFILL. I WAS SPLASHED IN THE EYE WITH 300 UNITS OF INSULIN¿. REPORTEDLY, THE CUSTOMER WENT TO THE EMERGENCY ROOM. MULTIPLE ATTEMPTS WERE MADE BY TANDEM TECHNICAL SUPPORT TO ADDRESS THE ISSUE; HOWEVER, NO RESPONSE WAS RECEIVED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687023 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male