BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 14593176 · Received June 3, 2022

    Report

    Report Number
    3013756811-2022-60504
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 18, 2022
    Report Date
    May 18, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00850006613717
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PUMP TOUCH SCREEN WAS UNRESPONSIVE. ADDITIONALLY, IT WAS REPORTED THAT AN AUTO-OFF ALARM OCCURRED. CUSTOMER ALLEGED THAT THERE HAD BEEN INTERACTION PRIOR TO ALARM. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 150-162 MG/DL. THE CUSTOMER REVERTED TO AN ALTERNATE METHOD IN INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866174 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1002717 00850006613717

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male