BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 13011481 · Received December 15, 2021

    Report

    Report Number
    3013756811-2021-137017
    Event Type
    Malfunction
    Date Received
    December 15, 2021
    Date of Event
    December 5, 2021
    Report Date
    December 15, 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

    Additional Manufacturer Narrative · 0

    DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP INDICATED A DATA LOG CORRUPTION. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 131-132 MG/DL. REPORTEDLY, CUSTOMER CONTINUED USING PUMP FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1909804 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 14 YR Male