BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6439104 · Received March 28, 2017

    Report

    Report Number
    3007981285-2017-08294
    Event Type
    Injury
    Date Received
    March 28, 2017
    Date of Event
    March 5, 2017
    Report Date
    March 28, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, DEVICE EVALUATION IS NOT YET COMPLETE. A SUPPLEMENTAL REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE TIMES THE MALFUNCTION ALARM OCCURRED AND THE PUMP STOPPED ALL INSULIN DELIVERY. CONTACT STATED THE CUSTOMER DID NOT GO BACK ON PUMP, BUT INSTEAD BEGAN USING MANUAL INJECTIONS. THE CUSTOMER'S BLOOD GLUCOSE (BG) WAS 230 - 444 MG/DL. THE CUSTOMER ADMINISTERED A MANUAL INJECTION TO ADDRESS HIGH BG LEVEL. MODERATE KETONE LEVELS WERE NOTED; THEREFORE, CONTACT CALLED HEALTH CARE PROVIDER (HCP) WHICH INSTRUCTED CUSTOMER TO USE INSULIN PENS UNTIL KETONES CAME DOWN. CUSTOMER ALSO DRANK WATER AND WAS ABLE TO BRING KETONES DOWN ON THE THEIR OWN. REPORTEDLY, MANUAL INJECTIONS WOULD BE USED FOR ALTERNATE INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221500 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Other