BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY

    MDR report key: 22968857 · Received September 4, 2025

    Report

    Report Number
    3013756811-2025-208978
    Event Type
    Injury
    Date Received
    September 4, 2025
    Date of Event
    August 12, 2025
    Report Date
    September 18, 2025
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00389152319810
    PMA / PMN Number
    K232380
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROL-IQ ALGORITHM DELIVERED AN AUTO-BOLUS IN RESPONSE TO THE CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READING; HOWEVER, THE CGM SENSOR READING WAS INACCURATE. REPORTEDLY, THE CGM BLOOD GLUCOSE (BG) READING WAS 200-249 MG/DL, AND THE METER BG READING WAS 167 MG/DL. THIS LEVEL OF INACCURACY DOES NOT PRESENT SIGNIFICANT MEDICAL RISK ACCORDING TO THE PARKES ERROR GRID. AS A RESULT OF THE AUTO-BOLUS, CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL LOWERED TO 45 MG/DL. BG WAS ADDRESSED VIA CONSUMPTION OF GLUCOSE TABLETS. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT DID NOT IDENTIFY ANY ADDITIONAL ISSUES WITH THE PUMP OR RELATED SUPPLIES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONTROL-IQ ALGORITHM DELIVERED AN AUTO-BOLUS IN RESPONSE TO THE CONTINUOUS GLUCOSE MONITOR (CGM) SENSOR READING; HOWEVER, THE CGM SENSOR READING WAS INACCURATE. REPORTEDLY, THE CGM BLOOD GLUCOSE (BG) READING WAS 200-249 MG/DL, AND THE METER BG READING WAS 167 MG/DL. THIS LEVEL OF INACCURACY DOES NOT PRESENT SIGNIFICANT MEDICAL RISK ACCORDING TO THE PARKES ERROR GRID. AS A RESULT OF THE AUTO-BOLUS, CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL LOWERED TO 45 MG/DL. BG WAS ADDRESSED VIA CONSUMPTION OF GLUCOSE TABLETS. REPORTEDLY, THE CUSTOMER TOOK MEDICATIONS THAT WERE KNOWN TO EFFECT CGM VALUES. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT DID NOT IDENTIFY ANY ADDITIONAL ISSUES WITH THE PUMP OR RELATED SUPPLIES. NO ADDITIONAL PATIENT OR EVENT INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017732 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ+ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1000354 00389152319810

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other