BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8671438 · Received June 5, 2019

    Report

    Report Number
    3013756811-2019-31031
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 12, 2019
    Report Date
    June 5, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE USER GUIDE: ALWAYS ENSURE THAT THERE ARE NO AIR BUBBLES IN THE TUBING WHEN FILLING. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED CONTINUOUS ELEVATED BLOOD GLUCOSE (BG 210-420 MG/DL). BOLUSES WERE DELIVERED, INFUSION SET CHANGED AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS BG. PUMP SYSTEM CHECK WAS PERFORMED AND AIR BUBBLES WERE OBSERVED IN THE TUBING. CUSTOMER CHANGED THE INFUSION SET. CUSTOMER REPORTED NOT TO HAVE REMOVED AIR FROM THE CARTRIDGE DURING THE LOADING PROCESS. TANDEM TECHNICAL SUPPORT INFORMED CUSTOMER THAT PER LABELING, AIR IS REQUIRED TO BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464385 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR