BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3951910 · Received July 7, 2014

    Report

    Report Number
    3007981285-2014-01978
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS AND GREATER, (B)(6).

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT CUSTOMER HAD AN OCCLUSION ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WENT HIGH (500 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394900 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other INFUSION SET: CONTACT DETACH| INSULIN: NOVOLOG