BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 19680915 · Received July 5, 2024

    Report

    Report Number
    3013756811-2024-114655
    Event Type
    Malfunction
    Date Received
    July 5, 2024
    Date of Event
    June 9, 2024
    Report Date
    July 31, 2024
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00389152000015
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION. D9, H3- REASON FOR NON-EVALUATION, H3- REMOVE: OTHER REASON, H3- DEVICE RETURNED TO MANUFACTURE, H10, H6 REMOVE- 3221, 4114, 67, H6 ADD- 11, 3233, 4118 D9, H3- REASON FOR NON-EVALUATION, H3- REMOVE: OTHER REASON, H3- DEVICE RETURNED TO MANUFACTURE, H10, H6 REMOVE- 3221, 4114, 67, H6 ADD- 11, 3233, 4118.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONGOING MALFUNCTION ALARMS OCCURRED. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE CUSTOMER¿S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901882 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00389152000015

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female