BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8272241 · Received January 23, 2019

    Report

    Report Number
    3013756811-2019-01859
    Event Type
    Injury
    Date Received
    January 23, 2019
    Date of Event
    December 29, 2018
    Report Date
    January 23, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS RANGING FROM 233-544 (MG/DL) WITH MODERATE KETONES. A BOLUS WAS DELIVERED VIA THE PUMP, A MANUAL INJECTION WAS ADMINISTERED, AND THE INFUSION SITE CHANGE WAS PERFORMED TO ADDRESS BG. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT; NO DEVICE ISSUE WAS IDENTIFIED. HOWEVER, CUSTOMER AND HEALTHCARE PROVIDER ALLEGED THE PUMP WAS NOT WORKING PROPERLY. REPORTEDLY, THE CUSTOMER HAD LANTUS AND NOVOLOG INSULIN AVAILABLE FOR DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63698 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other INFUSION SET: TRUSTEEL