BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 8134601 · Received December 5, 2018

    Report

    Report Number
    3013756811-2018-42698
    Event Type
    Injury
    Date Received
    December 5, 2018
    Date of Event
    November 13, 2018
    Report Date
    December 5, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    00853052007257
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE (BG 860-900 MG/DL). CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL FOR ELEVATED BG AND DIABETIC KETOACIDOSIS (DKA). INTRAVENOUS INSULIN AND ELECTROLYTES WERE ADMINISTERED. ELEVATED BG/DKA WERE RESOLVED AND CUSTOMER WAS DISCHARGED ON (B)(6) 2018 WITH NO PERMANENT DAMAGE. CUSTOMER ALLEGED PUMP WAS NOT DELIVERING INSULIN. PUMP SYSTEM CHECK WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND NO DEVICE ISSUE WAS IDENTIFIED. UPON FOLLOW UP, CUSTOMER REPORTED TO HAVE RESUMED PUMP THERAPY AND WAS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975173 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096 00853052007257

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R INFUSION SET: AUTOSOFT 30, INSULIN: HUMALOG