BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY

    MDR report key: 20127726 · Received September 3, 2024

    Report

    Report Number
    3013756811-2024-162671
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    August 10, 2024
    Report Date
    September 11, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    ON 9-6-2024, THE FOLLOWING INFORMATION WAS REPORTED: IT WAS REPORTED THAT THE CONTROL-IQ ALGORITHM DECREASED BASAL DELIVERY 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 80 MG/DL, AND THE METER BG READING RANGED FROM 800-828 MG/DL. THE PUMP WAS NOT RETURNED TO TANDEM DIABETES CARE; THEREFORE, A DEVICE EVALUATION WAS UNABLE TO BE PERFORMED. CONTROL-IQ TECHNOLOGY RELIES ON CURRENT CGM SENSOR READINGS AND WILL NOT BE ABLE TO ACCURATELY PREDICT BG LEVELS AND ADJUST INSULIN DELIVERY IF FOR ANY REASON THE CGM IS NOT FUNCTIONING PROPERLY. THE INFORMATION PROVIDED REGARDING THE EVENT IS INSUFFICIENT FOR DEXCOM TO PERFORM AN EVALUATION OF CGM SENSOR/TRANSMITTER DATA; THEREFORE, AN EVALUATION IS UNABLE TO BE PERFORMED FOR THIS EVENT. H6 (REMOVE CODE 2993, ADD CODES 1307 AND 2182), H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY HOSPITALIZED WITH A BLOOD GLUCOSE (BG) LEVEL OF 828 MG/DL AND A 550 MG/DL KETONE LEVEL IDENTIFIED AS DANGEROUS. REPORTEDLY, THE CUSTOMER SUSPECTED THAT THE CONTINUOUS GLUCOSE MONITOR SENSOR READING WAS INACCURATE RESULTING IN THE ELEVATED BG; HOWEVER, THIS COULD NOT BE CONFIRMED. THE CUSTOMER DID NOT INITIALLY TREAT THE HIGH BG. AT THE HOSPITAL, HEALTHCARE PROVIDERS ADMINISTERED INTRAVENOUS LACTATED RINGER'S 500CC, INSULIN, AND SODIUM BICARBONATE TO ADDRESS BG. A SYSTEM CHECK WAS PERFORMED, AND NO ISSUES WERE OBSERVED WITH THE PUMP, PUMP SUPPLIES, OR THE INSULIN IN USE AT THE TIME OF THE EVENT. CUSTOMER WAS RELEASED FROM THE HOSPITAL ON THE AUGUST 11TH, 2024 WITH THE ISSUE RESOLVED AND NO PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717748 T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown INSULIN TYPE: HUMALOG.