BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYS

    MDR report key: 3850460 · Received May 16, 2014

    Report

    Report Number
    3007981285-2014-00715
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    TANDEM DIABETES
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING IT WAS IDENTIFIED PT WAS FILING CARTRIDGES WITH INSULIN PENS. USE ONLY THE SYRINGE AND NEEDLE PROVIDED BY TANDEM DIABETES CARE, INC TO FILL THE CARTRIDGE.

    Description of Event or Problem · 1

    RECEIVED INFO STATING PT EXPERIENCED HIGH BG'S.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293834 TANDEM T:SLIM INSULIN DELIVERY SYS INSULIN PUMP LZG TANDEM DIABETES 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR