BEUDAMED
    FDA Adverse Event Death Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 13562068 · Received February 18, 2022

    Report

    Report Number
    3013756811-2022-17285
    Event Type
    Death
    Date Received
    February 18, 2022
    Date of Event
    January 21, 2022
    Report Date
    September 29, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED, AND EVALUATION IS PERFORMED.

    Additional Manufacturer Narrative · 0

    THE FAILURE INVESTIGATION HAS BEEN COMPLETED. THE PUMP DECLARED MULTIPLE CARTRIDGE ALARMS ON THE MORNING OF(B)(6) 2022 BEGINNING AT 8:24 AM, STOPPING INSULIN DELIVERY. FROM 7:56 AM TO 10:31 AM, THE USER¿S CONTINUOUS GLUCOSE MONITOR (CGM) VALUE ROSE FROM 81 MG/DL TO 285 MG/DL. THE CUSTOMER LAST ACKNOWLEDGED THESE ALARMS AT 10:13AM, AFTER WHICH THERE WAS NO FURTHER USER INTERACTION WITH THE DEVICE. THE PUMP CONTINUED TO ALARM EVERY 3 MINUTES TO INDICATE THAT THE PUMP WAS STILL IN AN ALARM STATE. AT 11:31 AM, THE USER RECEIVED A CGM ALERT, INDICATING THEIR GLUCOSE READING (73 MG/DL) WAS BELOW THE USER THRESHOLD (75 MG/DL). AT 11:36 AM, A CGM ALERT (CGM LOW ALERT) FOR A READING OF 55 MG/DL WAS ENUNCIATED. FROM 11:37 AM ONWARDS, THE SCREEN TURNED ON EVERY 3 MINUTES AND GAVE AN AUDIBLE ALARM SOUND TO INDICATE THE PUMP WAS STILL IN AN ALARM STATE, AND ALSO INDICATED IT WAS STILL IN A CGM ALERT STATE. FROM 11:51 AM TO 1:31 PM, THE USER¿S BG STAYED AT 40 MG/DL OR BELOW. BASED ON THE ANALYSIS, THE CUSTOMER'S GLUCOSE READINGS ARE OBSERVED TO BE DECREASING TO HYPOGLYCEMIC LEVELS BEGINNING AT 10:31AM ON (B)(6) 2022, EVEN THOUGH INSULIN DELIVERY WAS SUSPENDED AT 8:24 AM DUE TO THE ALARM STATE. THE PUMP WAS NOT IN USE AT THE TIME OF THE LOW BLOOD SUGAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER PASSED AWAY. REPORTEDLY, THE CUSTOMER HAD AN ELEVATED BLOOD GLUCOSE LEVEL PRIOR TO DEATH; HOWEVER, CAUSE OF DEATH HAD NOT YET BEEN DETERMINED AT THE TIME OF THE REPORT, AS AUTOPSY WAS NOT YET COMPLETED. THE PUMP IS EXPECTED TO BE RETURNED FOR EVALUATION AND A PUMP DATA REVIEW WILL BE PERFORMED. FOLLOW UP REPORT WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16565 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 24 YR Female Death