BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 12737475 · Received November 2, 2021

    Report

    Report Number
    3013756811-2021-118365
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 15, 2021
    Report Date
    November 2, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THIS COMPLAINT WAS INADVERTENTLY SUBMITTED. THE REPORTED EVENT WAS SUBMITTED UNDER MFG REPORT NUMBER 3013756811-2021-120982.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED MALFUNCTION ALARM OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS WITHIN RANGE (VALUE NOT PROVIDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636734 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 Unknown