BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 10495989 · Received September 4, 2020

    Report

    Report Number
    3013756811-2020-96300
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 18, 2020
    Report Date
    September 4, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    DEN180058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: ONLY USE U-100 HUMALOG OR U-100 NOVOLOG WITH YOUR PUMP. ONLY U-100 HUMALOG AND NOVOLOG HAVE BEEN TESTED AND FOUND TO BE COMPATIBLE FOR USE IN THE PUMP. USE OF INSULIN WITH LESSER OR GREATER CONCENTRATION CAN RESULT IN UNDER DELIVERY OR OVER DELIVERY OF INSULIN. THIS CAN CAUSE HYPOGLYCEMIA (LOW BG) OR HYPERGLYCEMIA (HIGH BG) EVENTS. 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 OCCLUSION ALARMS OCCURRED. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT, AND IT WAS DISCOVERED OCCLUSION WAS CAUSED BY A BLOCKAGE IN THE TUBING. HOWEVER, CUSTOMER REPORTED USING HUMALOG U500 INSULIN. TANDEM TECHNICAL SUPPORT INFORM CUSTOMER THAT HUMALOG U500 IS OFF LABEL PER THE USER GUIDE. CUSTOMER CHANGED PUMP SUPPLIES TO ADDRESS THE ISSUE AND RESUMED INSULIN DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 160-281 MG/DL AT TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960289 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR