BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 14793414 · Received June 23, 2022

    Report

    Report Number
    3013756811-2022-66921
    Event Type
    Malfunction
    Date Received
    June 23, 2022
    Date of Event
    June 5, 2022
    Report Date
    June 7, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE ALLEGED ISSUE COULD NOT BE VERIFIED; HOWEVER, A DAMAGED PIN ISSUE WAS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP WAS NOT EXPOSED TO EXTREME TEMPERATURES, BUT A TEMPERATURE ALARM OCCURRED. CUSTOMER CLEARED THE ALARM TO ADDRESS THE ISSUE; HOWEVER A REPLACEMENT PUMP WAS SENT TO THE CUSTOMER. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 130 - 158 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846510 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female