BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6071184 · Received November 1, 2016

    Report

    Report Number
    3007981285-2016-16748
    Event Type
    Injury
    Date Received
    November 1, 2016
    Date of Event
    October 7, 2016
    Report Date
    October 9, 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

    THE CAUSE OF THE REPORTED ISSUE WAS DUE TO THE INFUSION SET. TANDEM DOES NOT MANUFACTURE INFUSION SETS. 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 INSERTED INFUSION SET IMPROPERLY. BLOOD GLUCOSE (BG) LEVEL WAS IMPACTED (500 MG/DL) AND WAS ADDRESSED BY ADMINISTERING A MANUAL INJECTION. MULTIPLE ATTEMPTS WERE MADE BY TANDEM'S TECHNICAL SUPPORT TO OBTAIN INFUSION SET INFORMATION; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722496 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other INFUSION SET: UNKNOWN