BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 10993524 · Received December 11, 2020

    Report

    Report Number
    3013756811-2020-142054
    Event Type
    Malfunction
    Date Received
    December 11, 2020
    Date of Event
    November 27, 2020
    Report Date
    December 11, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004569
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 INTERMITTENT OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND IT WAS DISCOVERED OCCLUSION WAS CAUSED BY A BLOCKAGE IN THE CARTRIDGE. CUSTOMER CHANGED THE CARTRIDGE TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 170-250 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455244 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004569

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INFUSION SET: TRUSTEELINSULIN: NOVOLOG/NOVORAPID