BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 11848622 · Received May 19, 2021

    Report

    Report Number
    3013756811-2021-52850
    Event Type
    Malfunction
    Date Received
    May 19, 2021
    Date of Event
    May 2, 2021
    Report Date
    May 19, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BLOOD GLUCOSE (BG) LEVEL OF 253-300 MG/DL. TANDEM TECHNICAL SUPPORT PERFORMED A PUMP SYSTEM CHECK AND DETERMINED THAT INSULIN WAS NOT DELIVERING FROM THE CARTRIDGE. THE CARTRIDGE WAS CHANGED IN ATTEMPT TO RESOLVE THE ISSUE, HOWEVER, THE REPORTED ISSUE PERSISTED. CUSTOMER ALLEGED THE PUMP DID NOT FUNCTION AS INTENDED. IN ADDITION, IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743575 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR