BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5739733 · Received June 21, 2016

    Report

    Report Number
    3007981285-2016-86797
    Event Type
    Injury
    Date Received
    June 21, 2016
    Date of Event
    May 31, 2016
    Report Date
    May 31, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 LEVELS FROM (183-300 MG/DL) THE CUSTOMER TOOK BOLUSES VIA THE PUMP. THE CONTACT REPORTED THAT HEALTH CARE PROVIDER POSSIBLY CHANGED BASAL SETTINGS. HOWEVER, THE CONTACT WAS NOT SURE. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE CONTACT NOTED AIR BUBBLES IN THE INFUSION SET TUBING. THE CONTACT WAS ABLE TO EXPEL THE AIR BUBBLES BY PERFORMING A FILL TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392343 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other