BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7670493 · Received July 9, 2018

    Report

    Report Number
    3013756811-2018-22970
    Event Type
    Injury
    Date Received
    July 9, 2018
    Date of Event
    June 15, 2018
    Report Date
    July 9, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004538
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OCCLUSION ALARM OCCURRED. BLOOD GLUCOSE (BG) RANGED FROM 200-700 MG/DL. REPORTEDLY, CUSTOMER DID NOT TEST FOR KETONES. HOWEVER, CUSTOMER ANTICIPATED HAVING HIGH KETONES AND BELIEVED TO HAVE HIGH KETONES. REPORTEDLY, THE CUSTOMER'S HEALTHCARE PROVIDER IDENTIFIES HIGH KETONE LEVELS AS DANGEROUS/LIFE THREATENING. THE SUPPLIES WERE CHANGED TO ADDRESS THE EVENT AND A CORRECTION VIA THE PUMP WAS DELIVERED AS WELL AS A MANUAL INJECTION (MDI) TO ADDRESS BG. CUSTOMER REVERTED TO MDI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511491 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004538

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening INFUSION SET: CLEO, INSULIN: NOVOLOG