BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7480872 · Received May 2, 2018

    Report

    Report Number
    3013756811-2018-14740
    Event Type
    Malfunction
    Date Received
    May 2, 2018
    Date of Event
    April 10, 2018
    Report Date
    May 2, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE ALARM (CARTRIDGE ALARM 30) DURING BASAL DELIVERY. THE CUSTOMER WAS ABLE TO LOAD A NEW CARTRIDGE. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP SHUT DOWN UNEXPECTEDLY. CUSTOMER'S BLOOD GLUCOSE WAS 252-380 MG/DL. THE CUSTOMER CONFIRMED THAT AN ALTERNATE METHOD OF INSULIN DELIVERY WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321961 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR