BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8617508 · Received May 16, 2019

    Report

    Report Number
    3013756811-2019-26264
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    April 27, 2019
    Report Date
    May 16, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007325
    PMA / PMN Number
    P180008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CARTRIDGE ALARM (ALARM 1) AND AN UNIDENTIFIED MALFUNCTION ALARM OCCURRED. ANOTHER CARTRIDGE WAS LOADED TO RESOLVE THE CARTRIDGE ALARM. CUSTOMER DID NOT REPORT HOW THE MALFUNCTION ALARM WAS RESOLVED. CUSTOMER'S BLOOD GLUCOSE (BG) WAS 150-302 MG/DL. AT THE TIME OF THE REPORT, CUSTOMER'S BG WAS LOW (VALUE NOT REPORTED). CUSTOMER DECLINED TO PROVIDE FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409959 T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY AUTOMATED INSULIN DOSING, THRESHOLD SUSPEND OZO TANDEM DIABETES CARE 1000096 00853052007325

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other