BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3983416 · Received July 7, 2014

    Report

    Report Number
    3007981285-2014-01922
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT CUSTOMER FILLED TUBING AND NO DROPS CAME OUT OF THE END. REPORTEDLY, CUSTOMER STATED A SMELL OF INSULIN AND THAT PROBABLY INSULIN WAS COMING OUT OF THE LUER LOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394967 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR INFUSION SET: CLEO