BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6801335 · Received August 17, 2017

    Report

    Report Number
    3007981285-2017-23032
    Event Type
    Injury
    Date Received
    August 17, 2017
    Date of Event
    July 19, 2017
    Report Date
    August 17, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 INTERMITTENT ELEVATED BLOOD GLUCOSE (BG) LEVELS (200-572 MG/DL). THE CAUSE FOR ELEVATED BG LEVELS WAS UNKNOWN. CUSTOMER ADMINISTERED MANUAL INJECTIONS TO ADDRESS ELEVATED BG LEVELS. REPORTEDLY, CUSTOMER HAS RECENTLY SWITCHED FROM HUMALOG INSULIN TO NOVOLOG INSULIN. RECOMMENDATION WAS MADE TO DISCUSS DIABETES MANAGEMENT WITH CUSTOMER'S HEALTH CARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581812 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other INFUSION SET: CLEO 90, INSULIN: HUMALOG