BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8704875 · Received June 17, 2019

    Report

    Report Number
    3013756811-2019-33794
    Event Type
    Injury
    Date Received
    June 17, 2019
    Date of Event
    May 25, 2019
    Report Date
    June 17, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007318
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:SLIM X2 G5 USER GUIDE: ¿DO NOT USE ANY OTHER INSULIN WITH YOUR SYSTEM OTHER THAN U-100 HUMALOG OR NOVOLOG. ONLY HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE SYSTEM.¿ 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 MULTIPLE OCCLUSION ALARMS OCCURRED. CUSTOMER'S CONTINUOUS GLUCOSE MONITOR READ "HIGH," HOWEVER, SPECIFIC BLOOD GLUCOSE VALUE WAS NOT PROVIDED. A SYSTEM CHECK CONFIRMED THAT THE PUMP AND CARTRIDGE FUNCTIONED AS INTENDED AND THE OCCLUSION WAS LOCATED IN THE INFUSION SET TUBING. REPORTEDLY, CUSTOMER CHANGED THE INFUSION SET TUBING TO ADDRESS THE ISSUE. CUSTOMER WAS USING FIASP INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497334 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007318

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other INFUSION SET: AUTOSOFT 90, INSULIN: FIASP