BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY

    MDR report key: 8529207 · Received April 18, 2019

    Report

    Report Number
    3013756811-2019-20366
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Date of Event
    February 27, 2019
    Report Date
    April 18, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OZO
    UDI-DI
    00853052007264
    PMA / PMN Number
    P180008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CARTRIDGE INSTRUCTIONS FOR USE: REPLACE THE CARTRIDGE EVERY 48 HOURS IF USING HUMALOG; EVERY 72 HOURS IF USING NOVOLOG. MAKE SURE THAT INSULIN IS ROOM TEMPERATURE BEFORE FILLING THE CARTRIDGE. NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED CONTINUOUS ELEVATED BLOOD GLUCOSE (BG 200-239 MG/DL), CORRECTION BOLUSES WERE DELIVERED; HOWEVER, BG DID NOT LOWER. CUSTOMER ALLEGED THE CORRECTION FACTOR MAY NEED TO BE ADJUSTED. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT (CTS). PUMP TIME WAS FOUND TO BE INCORRECT; CAUSE WAS NOT KNOWN. CTS ASSISTED CUSTOMER WITH CORRECTING TIME. CUSTOMER ALSO REPORTED TO FILL THE CARTRIDGE WITH COLD INSULIN. THE PUMP CARTRIDGE WAS USED FOR 5-6 DAYS AND INFUSION SET SITE FOR MORE THAN 3 DAYS. CTS INFORMED CUSTOMER THAT THE SUPPLIES WERE USED LONGER THAN LABELING. CUSTOMER ACKNOWLEDGED. RECOMMENDATION WAS MADE FOR THE CUSTOMER TO DISCUSS EVENT WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323149 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 47 YR INFUSION SET: VARISOFT, INSULIN: NOVOLOG