BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6171452 · Received December 13, 2016

    Report

    Report Number
    3007981285-2016-24226
    Event Type
    Malfunction
    Date Received
    December 13, 2016
    Date of Event
    November 23, 2016
    Report Date
    November 23, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM USER GUIDE STATES, "NEVER FILL THE INFUSION SET TUBING WHILE THE TUBING IS CONNECTED TO YOUR BODY. FILLING THE TUBING WHILE IT IS CONNECTED TO YOUR BODY CAN RESULT IN THE UNINTENDED DELIVERY OF INSULIN." 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 DURING THE FILL TUBING PROCESS, THE CUSTOMER INITIALLY DISCONNECTED FROM THEIR SITE, OBSERVED INSULIN THEN CONNECTED THE TUBING TO THEIR SITE AND CONTINUED THE LOAD PROCESS WHILE CONNECTED. THE CUSTOMER REPORTED A BLOOD GLUCOSE (BG) LEVEL OF 138 (MG/DL). REPORTEDLY, THE CUSTOMER THOUGHT THEY WERE FILLING THE CANNULA AND REALIZED THEY WERE FILLING THE TUBING AGAIN. DURING TROUBLESHOOTING, IT WAS DETERMINED THAT THERE WAS POSSIBLY 7 UNITS OF INSULIN DELIVERED INTO THE CUSTOMER'S BODY. THE CUSTOMER'S BG LEVELS LATER STABILIZED TO 121 (MG/DL) AFTER FOOD WAS CONSUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822048 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR