BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6384516 · Received March 7, 2017

    Report

    Report Number
    3007981285-2017-06683
    Event Type
    Injury
    Date Received
    March 7, 2017
    Date of Event
    February 7, 2017
    Report Date
    March 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
    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD RECEIVED MULTIPLE, INTERMITTENT OCCLUSION ALARMS. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM NOT IMPACTED TO 265MG/DL AND A MANUAL INJECTION WAS ADMINISTERED TO ADDRESS THE BG LEVEL. THE CUSTOMER TROUBLESHOT THE ISSUE ON THEIR OWN AND FOUND THE OCCLUSION ALARM TO BE IN THE INFUSION SET TUBING EACH TIME. THE CUSTOMER WOULD CHANGE OUT THEIR INFUSION SET TUBING AND RESUME INSULIN DELIVERY. REPORTEDLY, THE CUSTOMER HAD BEEN USING HUMULIN U-500 INSULIN IN THE CARTRIDGE. TANDEM TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT HUMULIN U-500 WAS NOT LABELED TO BE USED WITH THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167868 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: U-500