BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM X2 INSULIN PUMP

    MDR report key: 7537933 · Received May 23, 2018

    Report

    Report Number
    3013756811-2018-16574
    Event Type
    Injury
    Date Received
    May 23, 2018
    Date of Event
    May 1, 2018
    Report Date
    May 23, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM'S T:SLIM X2 USER GUIDE, "DO NOT DELIVER A BOLUS UNTIL YOU HAVE REVIEWED THE CALCULATED BOLUS AMOUNT ON THE PUMP DISPLAY. IF YOU DOSE AN INSULIN AMOUNT THAT IS TOO HIGH OR TOO LOW, THIS COULD CAUSE VERY HIGH OR VERY LOW BLOOD GLUCOSE. YOU CAN ALWAYS ADJUST THE INSULIN UNITS UP OR DOWN BEFORE YOU DECIDE TO DELIVER YOUR BOLUS." 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 OBSERVED 32 UNITS OF INSULIN ON BOARD (IOB- ACTIVE INSULIN IN THE BODY) WITH 5 HOURS REMAINING BEING DISPLAYED. REPORTEDLY, AFTER CONSUMING DINNER THE CUSTOMER DELIVERED A BOLUS OF 16 UNITS. HOWEVER, THE CUSTOMER RECEIVED A VALID INCOMPLETE BOLUS ALERT DUE TO UNINTENTIONALLY EXITING THE BOLUS SCREEN, AND DELIVERED AN ADDITIONAL 16 UNITS DUE TO UNFAMILIARITY WITH THE ALERT. REVIEW OF THE BOLUS HISTORY BY TANDEM TECHNICAL SUPPORT VERIFIED THAT THE CUSTOMER HAD DELIVERED 2 BOLUSES, EACH FOR 16 UNITS EACH. TANDEM TECHNICAL SUPPORT EDUCATED THE CUSTOMER REGARDING IOB, AND THAT THE CUSTOMER HAD 32 UNITS OF INSULIN IN THE BODY. AT THE TIME OF THE REPORTED EVENT, THE CUSTOMER'S BG LEVEL RANGED FROM 131-138 (MG/DL). REPORTEDLY, EMERGENCY SERVICES WERE CONTACTED, AND THE CUSTOMER WAS PROVIDED WITH FAST-ACTING CARBOHYDRATES ALONG WITH SUSPENDING PUMP THERAPY TO ENSURE BG LEVEL REMAINED WITHIN RANGE. DURING A FOLLOW-UP CALL, THE CUSTOMER REPORTED BG LEVEL WAS OKAY AND AT THE TIME OF THE FOLLOW-UP, BG LEVEL WAS 184 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381769 T:SLIM X2 INSULIN PUMP INSULIN PUMP LZG TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention