BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 11842525 · Received May 18, 2021

    Report

    Report Number
    3013756811-2021-51666
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    February 1, 2021
    Report Date
    May 18, 2021
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 THE CUSTOMER RECEIVED A CONTINUOUS GLUCOSE MONITOR ERROR 42. THE PUMP WAS RESET, AND THE CUSTOMER CONTINUED TO USE THE PUMP FOR INSULIN THERAPY. IN ADDITION, IT WAS REPORTED THAT THE PUMP DATE WAS INACCURATE, CAUSE WAS UNKNOWN. CUSTOMER CORRECTED THE PUMP DATE TO RESOLVE THE ISSUE. CUSTOMER'S BLOOD GLUCOSE LEVEL RANGED FROM 170-350 MG/DL. LASTLY, THE CUSTOMER ALLEGED THAT TOUCHSCREEN HAD "GLITCHES". CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740337 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007264

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR