BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5914788 · Received August 30, 2016

    Report

    Report Number
    3007981285-2016-98438
    Event Type
    Injury
    Date Received
    August 30, 2016
    Date of Event
    August 6, 2016
    Report Date
    August 9, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED AN ELEVATED BLOOD GLUCOSE (BG) LEVEL BETWEEN 250-373 (MG/DL) AND MODERATE KETONES. CUSTOMER CHANGED THEIR INFUSION SET AND ADMINISTERED BOLUSES WITH THE PUMP AND MANUAL INJECTIONS TO TREAT THEIR BG LEVELS, BEFORE REVERTING TO AN OLD NON-TANDEM PUMP FOR DIABETES MANAGEMENT. RECOMMENDATION WAS MADE TO CONSULT WITH HEALTH CARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565429 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other