BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7777913 · Received August 13, 2018

    Report

    Report Number
    3013756811-2018-27748
    Event Type
    Injury
    Date Received
    August 13, 2018
    Date of Event
    July 20, 2018
    Report Date
    August 13, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257519117
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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 MULTIPLE, INTERMITTENT OCCLUSION ALARMS OCCURRED. CUSTOMER'S BLOOD GLUCOSE (BG) RANGED FROM 133-580 MG/DL. BG WAS ADDRESSED WITH A MANUAL INJECTION. REPORTEDLY, THE SUPPLIES WERE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618305 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257519117

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other INFUSION SET: AUTOSOFT 30, INSULIN: NOVOLOG