BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 16769403 · Received April 19, 2023

    Report

    Report Number
    3013756811-2023-55652
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    March 28, 2023
    Report Date
    April 19, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER CLEARED THE ALARM AND REPORTED THAT THE PUMP SUPPLIES WOULD BE CHANGED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 140-357 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1685466 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Male INFUSION SET: AUTOSOFT 30INSULIN TYPE: HUMALOG