BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 8617364 · Received May 16, 2019

    Report

    Report Number
    3013756811-2019-26082
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 16, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:FLEX USER GUIDE: ¿ONLY USE HUMALOG OR NOVOLOG U-100 INSULIN, AS ANY LESSER OR GREATER CONCENTRATION CAN RESULT IN SERIOUS HEALTH CONSEQUENCES. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED BY TANDEM DIABETES CARE, INC., AND FOUND TO BE COMPATIBLE FOR USE IN THE T:FLEX SYSTEM. IT IS NOT INTENDED FOR USE WITH ANY OTHER DELIVERY SUBSTANCE.¿ 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 MULTIPLE OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE REACHED 552 MG/DL AND A CORRECTION BOLUS VIA THE PUMP WAS DELIVERED. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE. CUSTOMER WAS USING U-500 INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408461 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other INFUSION SET: QUICKSET, INSULIN: U-500