BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10314455 · Received July 23, 2020

    Report

    Report Number
    3013756811-2020-72697
    Event Type
    Malfunction
    Date Received
    July 23, 2020
    Date of Event
    June 30, 2020
    Report Date
    July 23, 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

    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 INSULIN WAS NOT OBSERVED EXITING THE INFUSION SET TUBING DURING THE FILL TUBING STEP. MULTIPLE CARTRIDGES WERE USED. CUSTOMER CHANGED THE CARTRIDGE AND INFUSION SET TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE WAS 122-126 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781715 T:SLIM X2, BASAL-IQ, MMOL/L AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR INSULIN: HUMALOG, INFUSION SET: TRUSTEEL