BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5101380 · Received September 24, 2015

    Report

    Report Number
    3007981285-2015-53622
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    August 26, 2015
    Report Date
    August 26, 2015
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM'S T:SLIM USER GUIDE: "CHECK THAT YOUR LUER-LOCK CONNECTION BETWEEN THE CARTRIDGE TUBING AND THE INFUSION SET TUBING IS TIGHT AND SECURE." NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE LEVEL OF OVER 300 MG/DL. REPORTEDLY, THE CUSTOMER ATTEMPTED TO ADMINISTER A CORRECTION BOLUS. THE CUSTOMER STATED THAT THE LUER LOCK WAS LEAKING. DURING TROUBLESHOOTING WITH TANDEM'S TECHNICAL SUPPORT, THE CUSTOMER TIGHTENED THE LUER LOCK CONNECTION TO THE INFUSION SET AND WAS ABLE TO RESUME INSULIN DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633454 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE, INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other