BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19935123 · Received August 7, 2024

    Report

    Report Number
    3013756811-2024-140273
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 7, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K203234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, 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 311-312 MG/DL, AND THE METER BG READING WAS 122-123 MG/DL. AS A RESULT OF THE AUTO-BOLUS, CUSTOMERS EXPERIENCED A LOW BG DISPLAYED AS "LOW" ON CONTINUOUS GLUCOSE MONITOR. THE CUSTOMER REQUIRED ASSISTANCE TO CONSUME CARBOHYDRATE AND A GLUCOSE PACK TO ADDRESS BG. AROUND 18TH JULY, IT WAS REPORTED THAT THE CONTROL-IQ ALGORITHM SUSPENDED BASAL DELIVERY IN RESPONSE TO THE CGM SENSOR READING; HOWEVER, THE CGM SENSOR READING WAS INACCURATE. REPORTEDLY, THE CGM BG DISPLAYED AS "LOW" ON CONTINUOUS GLUCOSE MONITOR AND THE METER BG READING WAS 122-123 MG/DL. HOWEVER, AFTER CALIBRATION IT WAS REPORTED THAT THE CONTROL-IQ ALGORITHM DELIVERED AN AUTO-BOLUS IN RESPONSE TO THE CGM SENSOR READING; HOWEVER, THE CGM SENSOR READING WAS INACCURATE. REPORTEDLY, THE CGM BG READING WAS 306-307 MG/DL, AND THE METER BG READING WAS 162-163 MG/DL. THE CUSTOMER REQUIRED ASSISTANCE TO CONSUME CARBOHYDRATE AND A GLUCOSE PACK TO ADDRESS BG. SYSTEM CHECK WITH 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
    1209885 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY (WITH T:CONNECT MOBILE APP) ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown