BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:FLEX INSULIN DELIVERY SYSTEM

    MDR report key: 5168620 · Received October 22, 2015

    Report

    Report Number
    3007981285-2015-55966
    Event Type
    Injury
    Date Received
    October 22, 2015
    Date of Event
    September 26, 2015
    Report Date
    September 28, 2015
    Product Code
    LZG
    PMA / PMN Number
    K143189
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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 NOTICED AN AIR GAP. CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 200-260 MG/DL. REPORTEDLY, THE CUSTOMER DELIVERED A CORRECTION BOLUS. THE CUSTOMER CHANGED OUT THE SUPPLIES AND WAS ABLE TO LOWER BG LEVEL TO TARGET LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700071 T:FLEX INSULIN DELIVERY SYSTEM INFUSION PUMP LZG 004628-005

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other