BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6159636 · Received December 9, 2016

    Report

    Report Number
    3007981285-2016-23690
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    October 31, 2016
    Report Date
    November 22, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PER TANDEM¿S T:SLIM USER GUIDE: HUMALOG HAS BEEN TESTED BY TANDEM DIABETES CARE, INC. AND FOUND TO BE SAFE FOR USE IN THE T:SLIM PUMP. HUMALOG WAS TESTED FOR UP TO 48 HOURS AS LABELED. 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 IN LATE (B)(6) THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL OF 470 (MG/DL) WITH MODERATE KETONES. A MANUAL INJECTION WAS DELIVERED TO ADDRESS BG LEVEL. CUSTOMER STATED THE CAUSE OF THE ELEVATED BG LEVEL WAS UNKNOWN. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT AT THE TIME OF THE CALL INDICATED THE PUMP WAS PERFORMING AS INTENDED. REPORTEDLY THE CUSTOMER USED THE CARTRIDGE FOR 3 DAYS WITH HUMALOG INSULIN. THE CUSTOMER WAS INSTRUCTED BY TANDEM TECHNICAL SUPPORT ON CARTRIDGE AND INSULIN LABELING. A RECOMMENDATION WAS MADE FOR THE CUSTOMER TO DISCUSS ELEVATED BG LEVELS WITH THEIR HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814626 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other INFUSION SET: UNOMEDICAL T:90INSULIN: HUMALOG