BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7627340 · Received June 21, 2018

    Report

    Report Number
    3013756811-2018-21066
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    May 16, 2018
    Report Date
    June 21, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE CUSTOMER EXPERIENCED TRACE/SMALL KETONE LEVELS. HOWEVER, A HEALTHCARE PROVIDER IDENTIFIED THE KETONE LEVEL AS DANGEROUS/LIFE THREATENING. BLOOD GLUCOSE RANGED FROM 200-483 MG/DL. A SYSTEM CHECK WITH TANDEM¿S TECHNICAL SUPPORT VERIFIED THAT THE PUMP FUNCTIONED AS EXPECTED. MULTIPLE ATTEMPTS WERE MADE BY TANDEM¿S TECHNICAL SUPPORT TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470320 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Life Threatening