BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11386106 · Received February 26, 2021

    Report

    Report Number
    3013756811-2021-24892
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 11, 2021
    Report Date
    February 26, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM USER GUIDE: AVOID EXPOSURE OF YOUR PUMP TO TEMPERATURES BELOW 41°F (5°C) OR ABOVE 99°F (37°C). INSULIN CAN FREEZE AT LOW TEMPERATURES OR DEGRADE AT HIGH TEMPERATURES. INSULIN THAT HAS BEEN EXPOSED TO CONDITIONS OUTSIDE OF THE MANUFACTURER¿S RECOMMENDED RANGES CAN AFFECT THE SAFETY AND PERFORMANCE OF THE PUMP. 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. REPORTEDLY THE CUSTOMER EXPOSED THE PUMP TO EXTREME TEMPERATURES. TANDEM TECHNICAL SUPPORT INFORMED THE CUSTOMER THAT EXPOSING THE PUMP TO EXTREME TEMPERATURES IS OFF LABEL PER THE TANDEM USER GUIDE. CUSTOMER CHANGED THE PUMP SUPPLIES TO RESOLVE THE ISSUE. CUSTOMERS BLOOD GLUCOSE WAS 222- 400 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285658 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 48 YR