BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6435504 · Received March 27, 2017

    Report

    Report Number
    3007981285-2017-08011
    Event Type
    Injury
    Date Received
    March 27, 2017
    Date of Event
    March 3, 2017
    Report Date
    March 27, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, 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 HAD BEEN EXPERIENCING INTERMITTENT HIGH BLOOD GLUCOSE (BG) LEVELS (250 - 350 MG/DL) WITH A SMALL TO MODERATE LEVEL OF KETONES. THE CUSTOMER DID NOT KNOW THE CAUSE OF THE HIGH BG. A BOLUS VIA THE PUMP WAS DELIVERED TO ADDRESS THE HIGH BG. AFTER THE MORE RECENT HIGH BG, THE CUSTOMER REVERTED TO USING A NON-TANDEM PUMP TO DELIVER A BOLUS AND CONTINUED TO USE THE NON-TANDEM PUMP TO MANAGE DIABETES AS DIRECTED FROM THE HEALTHCARE PROVIDER. THE CUSTOMER'S BG WAS CURRENTLY STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218386 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other