BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 12439130 · Received September 8, 2021

    Report

    Report Number
    3013756811-2021-95223
    Event Type
    Malfunction
    Date Received
    September 8, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 8, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT WHILE CHARGING THE PUMP BATTERY THE PUMP UNEXPECTEDLY SHUT OFF. LOW POWER ALERTS AND SHUT OFF ALARM WERE RECEIVED. CUSTOMER UNPLUGGED AND RE-PLUGGED PUMP INTO A POWER SOURCE TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 122-124 MG/DL. CUSTOMER CONTINUED TO USE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1339082 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR