BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:CONNECT DATA MANAGEMENT SYSTEM

    MDR report key: 3905124 · Received May 29, 2014

    Report

    Report Number
    3007981285-2014-00845
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K122361
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DAILY INSULIN USE WAS A DIFFERENT VALUE ON THE DASHBOARD PAGE OF THE T:CONNECT DATA MANAGEMENT SYSTEM AS COMPARED WITH THE DAILY INSULIN USE VALUE ON THE ACTIVITY SUMMARY PAGE OF THE T:CONNECT DATA MANAGEMENT SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317464 TANDEM T:CONNECT DATA MANAGEMENT SYSTEM DATA MANAGEMENT SYSTEM LZG TANDEM DIABETES

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR