BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6070306 · Received November 1, 2016

    Report

    Report Number
    3007981285-2016-16670
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 9, 2016
    Report Date
    October 10, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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 AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 374 MG/DL WITH KETONES. THE CUSTOMER DELIVERED BOLUS AND INSULIN PEN INJECTIONS TO ADDRESS BG LEVEL. REPORTEDLY, THE CUSTOMER HAS BEEN SICK AND HAD NOT BEEN SLEEPING WELL, WHICH LED TO ELEVATED BG LEVEL. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTH CARE PROVIDER REGARDING DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720801 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other INSULIN: NOVOLOG, INFUSION SET: T:90