BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 10994663 · Received December 12, 2020

    Report

    Report Number
    3013756811-2020-143092
    Event Type
    Injury
    Date Received
    December 12, 2020
    Date of Event
    November 29, 2020
    Report Date
    December 11, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM USER GUIDE STATES: CHANGE YOUR INFUSION SET EVERY 48 TO 72 HOURS AS RECOMMENDED BY YOUR HEALTHCARE PROVIDER. CHECK YOUR INFUSION SET TUBING DAILY FOR ANY LEAKS, AIR BUBBLES, OR KINKS. AIR IN THE TUBING, LEAKS IN THE TUBING, OR KINKED TUBING MAY RESTRICT OR STOP INSULIN DELIVERY AND RESULT IN UNDER DELIVERY OF INSULIN. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL RANGING BETWEEN 882-900 MG/DL AND A 4.1 MMOL/L KETONE LEVEL RESULTING IN DIABETIC KETOACIDOSIS AND SUBSEQUENT HOSPITALIZATION. CORRECTIONS WERE ADMINISTERED VIA BOLUSES ON THE PUMP AND INSULIN PENS. CUSTOMER WAS TREATED VIA INSULIN DELIVERED INTRAVENOUSLY. DURING A FOLLOW-UP CALL, IT WAS FOUND THAT THE CUSTOMER HAD RECEIVED OCCLUSION ALARMS ON THE PUMP. ADDITIONALLY, THE CUSTOMER WAS NOT PERFORMING INFUSION SET CHANGES PER INSTRUCTIONS FOR USE; CUSTOMER HAD BEEN WEARING THE CURRENT INFUSION SET FOR OVER 3 DAYS. IN ADDITIONAL TO THE INFUSION SET OFF-LABEL USE, IT WAS ALSO DISCOVERED THAT THE CUSTOMER WAS NOT PERFORMING THE CORRECT STEPS DURING THE LOAD PROCESS; THE CUSTOMER HAD NOT BEEN FILLING THE INFUSION SET TUBING WITH INSULIN DURING THE LOAD PROCESS RESULTING IN AIR BEING DELIVERED TO THE CUSTOMER INSTEAD OF INSULIN (UNDER DELIVERY DUE TO USER ERROR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459737 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R