BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5635712 · Received May 5, 2016

    Report

    Report Number
    3007981285-2016-78595
    Event Type
    Injury
    Date Received
    May 5, 2016
    Date of Event
    April 15, 2016
    Report Date
    April 15, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP DECLARED AN UNSPECIFIED ALARM. CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG) LEVELS BETWEEN 200-392 (MG/DL) AND TRACE KETONES AND REVERTED TO MANUAL INJECTIONS TO ADDRESS BG LEVELS. CUSTOMER WAS DRIVING AT THE TIME EVENT WAS REPORTED; THEREFORE, TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT COULD NOT BE COMPLETED. RECOMMENDATION WAS MADE TO CONSULT WITH THEIR HEALTH CARE PROVIDER TO DISCUSS DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289585 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other