BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6323811 · Received February 10, 2017

    Report

    Report Number
    3007981285-2017-03143
    Event Type
    Injury
    Date Received
    February 10, 2017
    Date of Event
    January 5, 2017
    Report Date
    February 10, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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.

    Additional Manufacturer Narrative · 1

    PER TANDEM'S T:SLIM G4 USER GUIDE: INSULIN ON BOARD (IOB) IS ALWAYS DISPLAYED ON THE HOME SCREEN AND IS USED IN BOLUS DELIVERY CALCULATIONS WHEN APPLICABLE. WHEN A BG IS ENTERED DURING BOLUS PROGRAMMING, YOUR T:SLIM G4 PUMP WILL CONSIDER ANY ACTIVE IOB AND CALCULATE AN ADJUSTED BOLUS IF NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A LOW BLOOD GLUCOSE (BG) LEVEL OF 28-45 (MG/DL). TO TREAT THE LOW BG LEVEL, THE CUSTOMER CONSUMED GLUCAGON AND JUICE. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTH CARE PROVIDER REGARDING DIABETES MANAGEMENT. ALTHOUGH REQUESTED, THE CUSTOMER DECLINED TO UPLOAD THE PUMP DATA FOR TANDEM TECHNICAL SUPPORT TO PERFORM REVIEW OF THE PUMP DATA LOGS.

    Description of Event or Problem · 1

    THE CONTACT REPORTED THAT THE CUSTOMER HAD ENTERED A CARBOHYDRATE VALUE WITHOUT ADDING THE BLOOD GLUCOSE (BG) VALUE WHEN IMPUTING VALUES IN THE BOLUS MENU. AS A RESULT, THE INSULIN ON BOARD (IOB) WAS NOT BEING CONSIDERED IN THE CALCULATION OF A CARBOHYDRATE BOLUS AND CAUSED THE CUSTOMER'S LOW BG. TANDEM TECHNICAL SUPPORT EDUCATED THE CONTACT ON THE IOB FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105785 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 M018713

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other INSULIN: NOVOLOG