BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17690607 · Received September 6, 2023

    Report

    Report Number
    3013756811-2023-124296
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 6, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00085006613373
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    USE ERROR STMT: THE TANDEM PUMP USER GUIDE INSTRUCTS THE USER TO REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN O-RING WAS ON THE PNEUMATIC TAP. THE CUSTOMER WAS ABLE TO REMOVE THE O-RING FROM THE PUMP AND SUCCESSFULLY RELOADED THE EXISTING CARTRIDGE TO RESUME INSULIN THERAPY. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 130-252 MG/DL. IT WAS REPORTED THAT A CARTRIDGE ALARM OCCURRED. REPORTEDLY THE CUSTOMER DID NOT REMOVE ANY RESIDUAL AIR FROM THE CARTRIDGE. THERE WAS NO REPORTED ADVERSE IMPACT TO CUSTOMER'S BLOOD GLUCOSE LEVEL. REPORTEDLY, CUSTOMER LOADED A NEW CARTRIDGE TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056212 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00085006613373

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male