BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 10326533 · Received July 27, 2020

    Report

    Report Number
    3013756811-2020-78725
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    July 7, 2020
    Report Date
    July 27, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE LEVEL BETWEEN 212-400 MG/DL. REPORTEDLY, THE T:LOCK/LUER LOCK CONNECTION WAS NOT STRAIGHT/SECURE. REPORTEDLY, CUSTOMER DELIVERED A CORRECTION BOLUS TO RESOLVE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790436 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR INSULIN: NOVOLOG / NOVORAPIDINFUSION SET: AUTOSOF