BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 6869062 · Received September 15, 2017

    Report

    Report Number
    3007981285-2017-26334
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    August 26, 2017
    Report Date
    September 15, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM'S T:SLIM X2 USER GUIDE, "DO NOT FILL THE CARTRIDGE UNTIL PROMPTED BY INSTRUCTIONS ON THE PUMP SCREEN". 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 RECEIVED AN INACCURATE FILL ESTIMATE AFTER LOADING A CARTRIDGE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH APPROXIMATELY 270-300 UNITS OF INSULIN, AND AT THE TIME OF THE REPORTED EVENT, THE INSULIN GAUGE DISPLAYED 105 UNITS AND REMAINED STATIC. SUBSEQUENTLY, THE CUSTOMER PRE-FILLS THE CARTRIDGES. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 171-175 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649717 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR INSULIN: NOVOLOG, INFUSION SET: INSET