BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 16673572 · Received April 4, 2023

    Report

    Report Number
    3013756811-2023-45301
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    March 9, 2023
    Report Date
    April 4, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED DURING INSULIN DELIVERY WITH MULTIPLE CARTRIDGES. CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 120-330 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144573 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000354 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male