BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7915898 · Received September 27, 2018

    Report

    Report Number
    3013756811-2018-34534
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 12, 2018
    Report Date
    September 27, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257532071
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE X2 USER GUIDE STATE ¿HUMALOG® OR NOVOLOG® . ONLY HUMALOG® AND NOVOLOG® HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE VERY HIGH OR A VERY LOW BLOOD GLUCOSE.¿ PER TANDEM¿S USER GUIDE: ¿NEVER FILL YOUR TUBING WHILE YOUR INFUSION SET IS CONNECTED TO YOUR BODY. ALWAYS ENSURE THAT THE INFUSION SET IS DISCONNECTED FROM YOUR BODY BEFORE FILLING THE TUBING. FAILURE TO DISCONNECT YOUR INFUSION SET FROM YOUR BODY BEFORE FILLING THE TUBING CAN RESULT IN OVER DE¬LIVERY OF INSULIN. THIS CAN CAUSE SERIOUS INJURY OR DEATH FROM VERY LOW BLOOD GLUCOSE.¿ 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 MULTIPLE MINIMUM FILL NOTIFICATIONS OCCURRED AFTER FILLING MULTIPLE CARTRIDGES WITH 120-140 UNITS OF INSULIN. ADDITIONALLY, IT WAS REPORTED THAT THE CUSTOMER FILLED TUBING WHILE CONNECTED AT THE SITE. REPORTEDLY, A NEW CARTRIDGE WAS LOADED SUCCESSFULLY AND INSULIN DELIVERY WAS RESUMED. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL REACHED 221-301 MG/DL.

    Description of Event or Problem · 1

    CUSTOMER LOADED HUMALIN U100 INTO THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754939 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 M022071 00853052007257532071

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR