BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7726896 · Received July 27, 2018

    Report

    Report Number
    3013756811-2018-26997
    Event Type
    Malfunction
    Date Received
    July 27, 2018
    Date of Event
    July 16, 2018
    Report Date
    July 27, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257540684
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 ENCOUNTERED AN ISSUE WITH THE CARTRIDGE "NOT WORKING". A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. THE SPECIFIC ISSUE WAS NOT PROVIDED BY THE CUSTOMER. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200-360 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569151 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 M021052 00853052007257540684

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR