BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13001224 · Received December 14, 2021

    Report

    Report Number
    3013756811-2021-137994
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 29, 2021
    Report Date
    December 14, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613205
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    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 THE PUMP BATTERY WAS DEPLETING QUICKLY. ADDITIONALLY, IT WAS REPORTED THAT THE PUMP SHUT OFF UNEXPECTEDLY. THE CUSTOMER¿S BLOOD GLUCOSE WAS IN 150-199 MG/DL RANGE. THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1900124 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613205

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Male