BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7231058 · Received January 31, 2018

    Report

    Report Number
    3013756811-2018-02527
    Event Type
    Malfunction
    Date Received
    January 31, 2018
    Date of Event
    January 6, 2018
    Report Date
    January 31, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 MULTIPLE INTERMITTENT OCCLUSION ALARMS OCCURRED. A SYSTEM CHECK WITH TANDEM¿S TECHNICAL SUPPORT INDICATED THAT THE PUMP, CARTRIDGE, AND INFUSION SET FUNCTIONED AS EXPECTED. REPORTEDLY, THE CONTACT CHANGED THE SUPPLIES TO ADDRESS THE EVENT. BLOOD GLUCOSE RANGED FROM 200-315 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75961 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR