BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 9592367 · Received January 15, 2020

    Report

    Report Number
    3013756811-2020-02600
    Event Type
    Malfunction
    Date Received
    January 15, 2020
    Date of Event
    December 27, 2019
    Report Date
    January 15, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004569
    PMA / PMN Number
    K143189
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 AN OCCLUSION ALARM OCCURRED. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 220-240 MG/DL. REPORTEDLY, THE CUSTOMER CHANGED PUMP SUPPLIES TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55981 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG TANDEM DIABETES CARE 004628-005 M020877 00852162004569

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR INSULIN: NOVOLOG, INFUSION SET: AUTOSOFT 90