BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11665639 · Received April 14, 2021

    Report

    Report Number
    3013756811-2021-40604
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 14, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTERMITTENTLY, MULTIPLE CARTRIDGE ALARMS OCCURRED WITH MULTIPLE CARTRIDGES AFTER FILLING CARTRIDGE WITH 300 UNITS OF INSULIN. CUSTOMER REMOVED SOME INSULIN AND REINSTALLED CARTRIDGE TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 142-162 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561773 T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR INSULIN: NOVORAPID, INFUSION SET: AUTOSOFT 90