BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6653252 · Received June 20, 2017

    Report

    Report Number
    3007981285-2017-16521
    Event Type
    Injury
    Date Received
    June 20, 2017
    Date of Event
    May 28, 2017
    Report Date
    June 20, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, 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 HIGH BLOOD GLUCOSE (BG) LEVELS (284-380 MG/DL) AND INSULIN INJECTIONS WERE ADMINISTERED TO ADDRESS THE BG LEVEL. AFTER THE CURRENT CORRECTION USING AN INSULIN INJECTION, THE CUSTOMER'S BG DROPPED TO 30 MG/DL AND JUICE WAS CONSUMED TO ADDRESS THE LOW BG. THE CUSTOMER THOUGHT THE HIGH BG WAS DUE TO THE PUMP NOT DELIVERING INSULIN. AS THE CUSTOMER WAS NOT CURRENTLY EXPERIENCING A HIGH BG LEVEL, TANDEM TECHNICAL SUPPORT ADVISED THE CUSTOMER TO DISCUSS THE PAST EVENTS WITH A HEALTHCARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433992 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 M019064

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other INSULIN: HUMALOG, INFUSION SET: T:90