BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 16396882 · Received February 17, 2023

    Report

    Report Number
    3013756811-2023-25015
    Event Type
    Malfunction
    Date Received
    February 17, 2023
    Date of Event
    January 13, 2023
    Report Date
    February 17, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE CARTRIDGE USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. CUSTOMERS BLOOD GLUCOSE WAS 232-300 MG/DL. REPORTEDLY, THE CUSTOMER LOADED COLD INSULIN INTO THE CARTRIDGE. TANDEM TECHNICAL SUPPORT (CTS) EDUCATED CUSTOMER ON PROPER THE LOAD TECHNIQUES. THE CUSTOMER DECLINED FURTHER ASSISTANCE FROM CTS REGARDING THE ISSUE. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147425 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 0612566 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male INFUSION SET: AUTOSOFT XC