BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 10671890 · Received October 13, 2020

    Report

    Report Number
    3013756811-2020-108688
    Event Type
    Injury
    Date Received
    October 13, 2020
    Date of Event
    September 19, 2020
    Report Date
    October 13, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS IN 100-538 MG/DL RANGE WITH TRACE OF KETONES. ELEVATED BLOOD GLUCOSE WAS ADDRESS WITH CORRECTION BOLUS VIA PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134870 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Other INSULIN: HUMALOG, INFUSION SET: AUTOSOFT 90