BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7200206 · Received January 17, 2018

    Report

    Report Number
    3013756811-2018-01534
    Event Type
    Injury
    Date Received
    January 17, 2018
    Date of Event
    December 26, 2017
    Report Date
    January 17, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE, MINIMUM FILL NOTIFICATIONS OCCURRED AFTER FILLING A CARTRIDGE WITH 200-260 UNITS OF INSULIN. REPORTEDLY, ADDITIONAL INSULIN WAS ADDED TO THE EXISTING CARTRIDGE AND RELOADED SUCCESSFULLY. INSULIN DELIVERY WAS RESUMED. IN ADDITION, IT WAS REPORTED THE CUSTOMER'S PUMP CASE CLIP WAS LOOSE CAUSING THE PUMP TO FALL ON THE FLOOR AND PULL ON THE INFUSION SET. THE CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 477 (MG/DL) TO OVER 600 (MG/DL). A CORRECTION BOLUS WAS ADMINISTERED TO ADDRESS BG LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45325 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Other INSULIN: HUMALOG, INFUSION SET: T:90