BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 10943668 · Received December 4, 2020

    Report

    Report Number
    3013756811-2020-136018
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Date of Event
    November 18, 2020
    Report Date
    December 3, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE TANDEM USER GUIDE: ALWAYS MAKE SURE THAT THE CORRECT TIME AND DATE ARE SET ON YOUR INSULIN PUMP. NOT HAVING THE CORRECT TIME AND DATE SETTING MAY AFFECT SAFE INSULIN DELIVERY. WHEN EDITING TIME, ALWAYS CHECK THAT THE AM/PM SETTING IS ACCURATE, IF APPLICABLE. 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 THE PUMP TIME WAS INCORRECT DUE TO NOT HAVING BEEN ADJUSTED FOR DAYLIGHT SAVING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS BETWEEN 161-221 MG/DL. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410282 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INFUSION SET: AUTOSOFT XCINSULIN: NOVOLOG