BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 5717723 · Received June 10, 2016

    Report

    Report Number
    3007981285-2016-85844
    Event Type
    Injury
    Date Received
    June 10, 2016
    Date of Event
    May 15, 2016
    Report Date
    May 19, 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

    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 CUSTOMER HAD BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE (BG) LEVELS OF 250-350 (MG/DL). CUSTOMER CHANGED INFUSION SITES AND ADMINISTERED CORRECTION BOLUSES TO TREAT BG LEVELS; HOWEVER, BG LEVELS HAVE REMAINED ELEVATED. SYSTEM CHECK WITH TANDEM TECHNICAL SUPPORT ON (B)(6) 2016 INDICATED PUMP WAS PERFORMING AS INTENDED. CUSTOMER INDICATED THAT THEY WILL CONTINUE TO MONITOR BG LEVELS AND CONTACT THEIR HEALTH CARE PROVIDER IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371536 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 M016125

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other INFUSION SET: INSET, INSULIN: NOVOLOG