BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852567 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-35394
    Event Type
    Injury
    Date Received
    June 17, 2015
    Date of Event
    May 22, 2015
    Report Date
    May 27, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM ON (B)(6) 2015 DUE TO DIABETIC KETOACIDOSIS. CUSTOMER WAS TREATED WITH INSULIN AND FLUID DRIP, AND RELEASED THE SAME DAY. CUSTOMER NEVER WENT THROUGH TRAINING FOR THE PUMP. REPORTEDLY, THE CUSTOMER TRAINED HERSELF THROUGH ONLY THE USER MANUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394558 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention