BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12763090 · Received November 7, 2021

    Report

    Report Number
    3013756811-2021-118855
    Event Type
    Malfunction
    Date Received
    November 7, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 5, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING BOLUS DELIVERY. ADDITIONALLY. IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. IT WAS ALSO REPORTED THAT AN ALTITUDE ALARM OCCURRED. REPORTEDLY, THE PUMP WAS NOT OUTSIDE THE LABELED ALTITUDE OPERATING RANGE. REPORTEDLY, A SUPPLY CHANGE WAS PERFORMED RESOLVING THE REPORTED ISSUES, AND INSULIN DELIVERY WAS RESUMED. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 151-167 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1656749 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Female