BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 17828085 · Received September 27, 2023

    Report

    Report Number
    3013756811-2023-137741
    Event Type
    Malfunction
    Date Received
    September 27, 2023
    Date of Event
    September 4, 2023
    Report Date
    September 27, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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. USE ERROR. PER THE USER GUIDE: WARNING - NEVER FILL YOUR TUBING WHILE YOUR INFUSION SET IS CONNECTED TO YOUR BODY. ALWAYS ENSURE THAT THE INFUSION SET IS DISCONNECTED FROM YOUR BODY BEFORE FILLING THE TUBING. FAILURE TO DISCONNECT YOUR INFUSION SET FROM YOUR BODY BEFORE FILLING THE TUBING CAN RESULT IN OVER DELIVERY OF INSULIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER INADVERTENTLY PERFORMED THE LOAD SEQUENCE WHILE CONNECTED TO THE SITE. THE CUSTOMER'S BLOOD GLUCOSE WAS 142-184 MG/DL. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER TO NOT BE CONNECTED TO THE PUMP DURING THE FILL TUBING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830916 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000354 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female