BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6191074 · Received December 20, 2016

    Report

    Report Number
    3007981285-2016-26570
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 10, 2016
    Report Date
    December 10, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:SLIM G4 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 USER NOTICED THE LUER LOCK WAS LEAKING. REPORTEDLY, THE USER ADJUSTED THE LUER LOCK CONNECTION SO THAT IT SECURE AND STRAIGHT. THEN THE USER NOTICED LARGE GAPS OF AIR IN THE INFUSION SET TUBING. THE USER PRIMED THE TUBING TO SUCCESSFULLY REMOVE AIR BUBBLES AND RESUMED INSULIN DELIVERY. THE USER'S BLOOD GLUCOSE LEVEL WAS 71 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838904 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR