BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP)

    MDR report key: 21821649 · Received April 10, 2025

    Report

    Report Number
    3013756811-2025-69975
    Event Type
    Injury
    Date Received
    April 10, 2025
    Date of Event
    April 7, 2025
    Report Date
    May 5, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    B2 OUTCOMES: HOSPITALIZATION: YES; REQUIRED INTERVENTION: YES; B5: REMOVE HEALTH EFFECT IMPACT CODE: 4613.

    Additional Manufacturer Narrative · 0

    PER TANDEM USER GUIDE: CHANGE YOUR CARTRIDGE EVERY 48¿72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY. IT WAS ALSO REPORTED THE CUSTOMER WENT TO THE HOSPITAL WITH A BLOOD GLUCOSE (BG) LEVEL WAS 300-560 MG/DL. BG LEVEL WAS ADDRESSED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. REPORTEDLY, THE CARTRIDGE AND INFUSION SET HAD BEEN IN USE FOR MORE THAN 48 HOURS WITH HUMALOG INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON INSULIN LABELING. CUSTOMER WAS RELEASED FROM THE HOSPITAL WITH ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TIME WAS INCORRECT, CAUSE WAS UNKNOWN. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CUSTOMER CORRECTED THE TIME AND RESUMED INSULIN THERAPY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS G MG/DL. BG LEVEL WAS ADDRESSED WITH A CORRECTION BOLUS VIA THE PUMP. REPORTEDLY, THE CARTRIDGE AND INFUSION SET HAD BEEN IN USE FOR MORE THAN 48 HOURS WITH HUMALOG INSULIN. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER ON INSULIN LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2425602 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female