BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 8739780 · Received June 27, 2019

    Report

    Report Number
    3013756811-2019-38678
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    June 6, 2019
    Report Date
    June 27, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004569
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. REPORTEDLY, THE CUSTOMER WAS USING U-500 INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON LABELED INSULIN USAGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 360 MG/DL. REPORTEDLY, THE CUSTOMER WENT TO THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO FOLLOW UP WITH THE CUSTOMER; HOWEVER, NO RESPONSE WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533556 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004569

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R