BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3905194 · Received May 29, 2014

    Report

    Report Number
    3007981285-2014-00860
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DURING FURTHER TROUBLESHOOTING IT WAS IDENTIFIED LUER WAS LOOSE AND PATIENT COULD SMELL INSULIN. T:SLIM USER GUIDE STATES: CHECK THAT YOUR LUER-LOCK CONNECTION BETWEEN THE CARTRIDGE TUBING AND THE INFUSION SET. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING PATIENT HAS BEEN EXPERIENCING HIGH BG'S (150-195 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317232 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR