BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 21060645 · Received January 2, 2025

    Report

    Report Number
    3013756811-2025-01730
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 17, 2024
    Report Date
    January 2, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152370019
    PMA / PMN Number
    K233044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE CANISTER. CUSTOMER PERFORMED A SUPPLY CHANGE TO RESOLVE THE ISSUE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 153 - 184 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554134 TANDEM MOBI INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1004000 W1291406 00389152370019

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female