BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12268373 · Received August 3, 2021

    Report

    Report Number
    3013756811-2021-82291
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    July 11, 2021
    Report Date
    August 3, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613779
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 A MINIMUM FILL NOTIFICATION OCCURRED AFTER THE USER FILLED THE CARTRIDGE WITH 300 UNITS OF INSULIN DURING THE LOAD SEQUENCE. A NEW CARTRIDGE WAS LOADED TO RESOLVE THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN FILLING THE CARTRIDGE DURING THE LOAD SEQUENCE. REPORTEDLY, THE ISSUE RESOLVED AND CUSTOMER WAS ABLE TO FILL THE EXISTING CARTRIDGE WITH THE EXISTING NEEDLE. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 151-188 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1165771 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 M938395 00850006613779

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INSULIN TYPE: HUMALOG