BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 16701921 · Received April 7, 2023

    Report

    Report Number
    3013756811-2023-45693
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 13, 2023
    Report Date
    April 7, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 LOSSES OF OUT OF RANGE ISSUES OCCURRED BETWEEN THE TRANSMITTER AND PUMP. THE CUSTOMERS BLOOD GLUCOSE LEVEL WAS REPORTED BETWEEN 160-171 MG/DL. REPORTEDLY, THE PUMP AND TRANSMITTER REGAINED CONNECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441322 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female