BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 11201261 · Received January 20, 2021

    Report

    Report Number
    3013756811-2021-05559
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 28, 2020
    Report Date
    December 28, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    852162004439
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE CUSTOMER INADVERTENTLY ENABLED THE FEATURE LOCK SETTINGS. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, SETTING WAS DISABLED AND INSULIN DELIVERY WAS SUCCESSFULLY RESUMED. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 146-251 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101139 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 852162004439

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR