BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 16860793 · Received May 3, 2023

    Report

    Report Number
    3013756811-2023-59556
    Event Type
    Malfunction
    Date Received
    May 3, 2023
    Date of Event
    April 9, 2023
    Report Date
    May 26, 2023
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613731
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP BATTERY COULD NOT BE CHARGED. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 100-156 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544534 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000354 00850006613731

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female