BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15199257 · Received August 10, 2022

    Report

    Report Number
    3013756811-2022-85920
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 22, 2022
    Report Date
    July 22, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007301
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND EVALUATION IS PERFORMED. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING BOLUS DELIVERY. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ISSUE. ADDITIONALLY, IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. A SUPPLY CHANGE WAS PERFORMED RESOLVING THE OCCLUSION. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS APPROXIMATELY 200-370 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399330 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 W0459612 00853052007301

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male