BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8108285 · Received November 27, 2018

    Report

    Report Number
    3013756811-2018-43307
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    November 7, 2018
    Report Date
    November 27, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    UDI-DI
    00852162004545
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    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 ONGOING ELEVATED BLOOD GLUCOSE (BG) LEVELS (221-550 MG/DL). THE CAUSE FOR ELEVATED BG LEVELS WAS UNKNOWN. CUSTOMER ADDRESSED ELEVATED BG LEVELS WITH A CORRECTION BOLUS. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH CUSTOMER'S HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    944360 T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 00852162004545

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other