BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9934181 · Received April 8, 2020

    Report

    Report Number
    3013756811-2020-32836
    Event Type
    Malfunction
    Date Received
    April 8, 2020
    Date of Event
    March 3, 2020
    Report Date
    April 7, 2020
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    P180008
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE CARTRIDGE ALARMS (ALARM 30) OCCURRED DURING PUMPING. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 251-288 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403104 T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR