BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11876155 · Received May 25, 2021

    Report

    Report Number
    3013756811-2021-54835
    Event Type
    Malfunction
    Date Received
    May 25, 2021
    Date of Event
    April 20, 2021
    Report Date
    May 25, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER ADDRESSED ALARMS BY CHANGING OUT PUMP SUPPLIES AND RESUMING INSULIN DELIVERY. SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT FOR AND NO ISSUES WERE IDENTIFIED; HOWEVER, CUSTOMER WAS USING FIASP INSULIN. TANDEM TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT FIASP IS OFF-LABEL PER USER GUIDE. CUSTOMER'S BLOOD GLUCOSE WAS 233-240 MG/DL AT TIME OF ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777799 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR INFUSION SET: AUTOSOFT XCINSULIN: FIASP