BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6850049 · Received September 7, 2017

    Report

    Report Number
    3007981285-2017-25491
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    August 18, 2017
    Report Date
    September 7, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    T:FLEX USER GUISE STATES: 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED AN OCCLUSION ALARM OCCURRED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 250MG/DL AND A CORRECTION BOLUS VIA THE PUMP WAS DELIVERED TO ADDRESS THE BG LEVEL. THE CUSTOMER PERFORMED TROUBLESHOOTING ON THEIR OWN PRIOR TO CONTACTING TANDEM TECHNICAL SUPPORT AND FOUND THE OCCLUSION TO BE WITHIN THE CARTRIDGE. REPORTEDLY, THE CUSTOMER USES U-500 INSULIN IN THEIR CARTRIDGE. CTS INFORMED THE CUSTOMER THAT U-500 IS CONTRAINDICATED FOR USE WITH THE PUMP. A CARTRIDGE CHANGE WAS PERFORMED TO ADDRESS THE OCCLUSION ALARM AND INSULIN DELIVERIES WERE RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628930 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M020664

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other