BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8311818 · Received February 6, 2019

    Report

    Report Number
    3013756811-2019-05270
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    January 14, 2019
    Report Date
    February 6, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007271
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CARTRIDGE USER GUIDE CAUTIONS THAT INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE USE OR AIR BUBBLES COULD FORM IN THE CARTRIDGE. THE X2 PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE. CUSTOMER¿S BLOOD GLUCOSE WAS 133-260 MG/DL. CUSTOMER LOADED COLD INSULIN INTO THE CARTRIDGE AND DID NOT PRACTICE PROPER AIR REMOVAL TECHNIQUE. REPORTEDLY, THE CUSTOMER CONTINUED TO USE THE EXISTING CARTRIDGE AND THE INSULIN GAUGE BEGAN TO DECREASE AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106179 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007271

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR