BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13079631 · Received December 23, 2021

    Report

    Report Number
    3013756811-2021-143605
    Event Type
    Malfunction
    Date Received
    December 23, 2021
    Date of Event
    December 10, 2021
    Report Date
    December 23, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED.

    Additional Manufacturer Narrative · 0

    THE INITIAL MEDWATCH WAS SUBMITTED INADVERTENTLY. AS THE REPORT WAS SUBMITTED VIA MFG REPORT # 3013756811-2021-143415. THE INITIAL MEDWATCH WAS SUBMITTED INADVERTENTLY. AS THE REPORT WAS SUBMITTED VIA MFG REPORT # 3013756811-2021-143415.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY WITH MULTIPLE CARTRIDGES. THERE WAS NO ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE. CUSTOMER CONSULTED WITH HEALTH CARE PROVIDER REGARDING BACKUP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1973394 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown