BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 6747729 · Received July 27, 2017

    Report

    Report Number
    3007981285-2017-20993
    Event Type
    Injury
    Date Received
    July 27, 2017
    Date of Event
    July 4, 2017
    Report Date
    July 27, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE T:FLEX USER GUIDE: REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG®; EVERY 72 HOURS IF USING NOVOLOG®. 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 BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (230-400 MG/DL). THE PUMP SUPPLIES WERE CHANGED AND A BOLUS WAS DELIVERED TO ADDRESS THE BG LEVEL. THE CUSTOMER DID NOT KNOW THE CAUSE OF THE HIGH BG. A PUMP SYSTEM CHECK WAS PERFORMED AND NO DEVICE ISSUES WERE IDENTIFIED. THE CUSTOMER REPORTED TO HAVE BEEN USING HUMALOG FOR 3 DAYS IN THE CARTRIDGE. TANDEM TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT HUMALOG WAS LABELED FOR 48 HOURS WITH THE PUMP. THE CUSTOMER UNDERSTOOD THE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527061 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other INSULIN: HUMALOG