BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 8323562 · Received February 8, 2019

    Report

    Report Number
    3013756811-2019-05146
    Event Type
    Malfunction
    Date Received
    February 8, 2019
    Date of Event
    January 18, 2019
    Report Date
    February 8, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004385
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM'S T:FLEX USER GUIDE, "IT IS VERY IMPORTANT TO SET THE CURRENT TIME AND DATE ACCURATELY TO ENSURE SAFE INSULIN DELIVERY." 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 SET THE PUMP TIME WAS INACCURATE BY 3 MINUTES. BLOOD GLUCOSE RANGED FROM 230-301 (MG/DL). TANDEM TECHNICAL SUPPORT ASSISTED THE CUSTOMER WITH ADJUSTING THE PUMP TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115560 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 00852162004385

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR INSULIN: HUMULIN, INFUSION SET: AUTOSOFT 90