BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5697404 · Received June 3, 2016

    Report

    Report Number
    3007981285-2016-82711
    Event Type
    Injury
    Date Received
    June 3, 2016
    Date of Event
    April 30, 2016
    Report Date
    May 14, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS RANGING FROM (200-487 MG/DL) THE CUSTOMER WOULD CHANGE SUPPLIES AND BOLUS VIA THE PUMP TO STABILIZE BG LEVEL. THE CONTACT SAID TO BE UNSURE ON WHAT COULD BE THE CAUSE OF THE ELEVATED BG LEVELS AND BELIEVED THE PUMP TO THE ISSUE. A SYSTEM CHECK WAS PERFORMED DURING THE CALL WITH TANDEM TECHNICAL SUPPORT, INDICATING THE PUMP WAS FUNCTIONING AS INTENDED. THE CONTACT STATED THAT THE HEALTH CARE PROVIDER (HCP) HAD CHANGED CUSTOMERS BASAL AND CARBOHYDRATE RATIO AND THAT THE CUSTOMER OCCASIONALLY FORGETS TO TAKE A BOLUS AFTER A SNACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352763 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other