BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6364292 · Received February 28, 2017

    Report

    Report Number
    3007981285-2017-05918
    Event Type
    Injury
    Date Received
    February 28, 2017
    Date of Event
    February 6, 2017
    Report Date
    February 28, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 289 MG/DL AND A CORRECTION BOLUS WAS DELIVERED TO ADDRESS THE BG LEVEL. A PUMP SYSTEM CHECK WAS PERFORMED AND THE OCCLUSION WAS FOUND TO BE WITHIN THE INFUSION SET TUBING. TANDEM TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER IN CHANGING THE INFUSION SET TUBING AND THE CUSTOMER SUCCESSFULLY RESUMED INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER USES HUMULIN U-500 IN THEIR CARTRIDGE, CTS INFORMED THE CUSTOMER THAT HUMULIN U-500 IS CONTRAINDICATED FOR USE WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149023 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other INFUSION SET: T90, INSULIN: HUMULIN U-500