BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6438933 · Received March 28, 2017

    Report

    Report Number
    3007981285-2017-08695
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    February 8, 2017
    Report Date
    March 28, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 BY THE CONTACT THAT THE CUSTOMER HAD BEEN EXPERIENCING ONGOING HIGH BLOOD GLUCOSE (BG) LEVELS (100-590 MG/DL) WITH MODERATE LEVELS OF KETONES. BOLUSES AND INSULIN INJECTIONS WERE USED TO ADDRESS THE HIGH BG LEVEL. WATER WAS CONSUMED TO FLUSH OUT THE KETONES. A PUMP SYSTEM CHECK WAS PERFORMED USING THE CURRENT SUPPLIES ON THE PUMP AND NO DEVICE ISSUES WERE IDENTIFIED. NO ISSUES WERE OBSERVED WITH THE CANNULAS. REPORTEDLY, THE CUSTOMER USED HUMALOG IN THE CARTRIDGE FOR 4 DAYS. TANDEM CUSTOMER TECHNICAL SUPPORT (CTS) INFORMED THE CONTACT THAT HUMALOG WAS LABELED FOR 48 HOURS USE WITH THE PUMP. CTS REVIEWED THE PUMP DATA AND NO DEVICE DEFICIENCY WAS IDENTIFIED. THE CONTACT WAS DISSATISFIED WITH THE CUSTOMER USING THE PUMP; HOWEVER, WILL HAVE THE CUSTOMER CONTINUE TO USE THE PUMP TO MANAGE DIABETES. CTS ADVISED THE CONTACT TO DISCUSS THE EVENT WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221943 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other