BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7049214 · Received November 21, 2017

    Report

    Report Number
    3007981285-2017-34539
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    November 2, 2017
    Report Date
    November 21, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THAT THE CUSTOMER EXPERIENCED BLOOD GLUCOSE (BG) LEVELS RANGING FROM 500-600 AND DIABETIC KETOACIDOSIS (DKA). THE CUSTOMER RECEIVED INTRAVENOUS FLUIDS FROM THE HEALTH CLINIC. THE CUSTOMER LEFT THE HEALTH CLINIC ON (B)(6) 2017. REPORTEDLY, THE SUSPECTED CAUSE OF THE ELEVATED BG LEVEL WAS UNKNOWN. ALTHOUGH REQUESTED, THE CONTACT DECLINED TO PERFORM TROUBLESHOOTING FOR THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828054 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention