BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2, BASAL-IQ, MMOL/L

    MDR report key: 11729009 · Received April 26, 2021

    Report

    Report Number
    3013756811-2021-45639
    Event Type
    Injury
    Date Received
    April 26, 2021
    Date of Event
    April 3, 2021
    Report Date
    April 26, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613021
    PMA / PMN Number
    K201214
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. PER THE USER GUIDE: DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DOSE AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE VERY HIGH OR VERY LOW BLOOD GLUCOSE. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED AND RESOLVED PRIOR TO TIME OF REPORT. CUSTOMER'S BLOOD GLUCOSE (BG) WAS 162-180 MG/DL AND AN INSULIN INJECTION WAS USED TO ADDRESS BG. CUSTOMER REPORTED TO HAVE DELIVERED A "BIG BOLUS" WHICH LED TO A LOW BG (51 MG/DL). CARBOHYDRATES WERE CONSUMED TO ADDRESS LOW BG. CUSTOMER RESUMED PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621603 T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00850006613021

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other INFUSION SET: AUTOSOFT 90, INSULIN: NOVORAPID