BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 17173645 · Received June 21, 2023

    Report

    Report Number
    3013756811-2023-85565
    Event Type
    Malfunction
    Date Received
    June 21, 2023
    Date of Event
    May 30, 2023
    Report Date
    June 21, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    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 RANGED FROM 250-276 MG/DL, AND THE METER BG READING WAS 66 MG/DL. AS A RESULT OF THE AUTO-BOLUS, CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL LOWERED RANGING FROM 66-170 MG/DL. BG WAS ADDRESSED VIA CONSUMPTION OF CARBOHYDRATES. 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
    2213883 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male