BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11298578 · Received February 8, 2021

    Report

    Report Number
    3013756811-2021-11405
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    January 16, 2021
    Report Date
    February 8, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TANDEM USER GUIDE INDICATES THAT HUMALOG AND NOVOLOG HAVE BEEN TESTED UP TO 48 AND 72 HOURS RESPECTIVELY. 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 INSULIN GAUGE WAS INACCURATE AND STATIC. CUSTOMER REPORTED USING CARTRIDGE FOR MORE THAN THREE DAYS. TANDEM TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT THIS IS OFF LABEL PER THE USER GUIDE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 120-187 MG/DL. CUSTOMER DECLINED FURTHER TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189156 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 67 YR