BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G5 SYSTEM

    MDR report key: 7625212 · Received June 21, 2018

    Report

    Report Number
    3013756811-2018-20916
    Event Type
    Injury
    Date Received
    June 21, 2018
    Date of Event
    March 29, 2018
    Report Date
    June 21, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. PER THE USER GUIDE: DO NOT REUSE CARTRIDGES OR USE CARTRIDGES OTHER THAN THOSE MANUFACTURED BY TANDEM DIABETES CARE, INC. USE OF CARTRIDGES NOT MANUFACTURED BY TANDEM DIABETES CARE, INC. OR REUSE OF CARTRIDGES MAY RESULT IN OVER DELIVERY OR UNDER DELIVERY OF INSULIN. THIS CAN CAUSE VERY LOW OR VERY HIGH BLOOD GLUCOSE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED MULTIPLE ALTITUDE ALARMS AND THERE WAS A DELAY IN CLEARING THE ALARMS. BLOOD GLUCOSE (BG) WAS POSSIBLY GREATER THAN 500 MG/DL WITH KETONES. BOLUS VIA THE PUMP WAS DELIVERED. THE CUSTOMER WENT TO THE EMERGENCY ROOM AND WAS ADMITTED TO THE HOSPITAL. THE CUSTOMER WAS TREATED WITH INTRAVENOUS FLUIDS/INSULIN. CUSTOMER REPORTED THAT THE CARTRIDGE WAS RE-USED MULTIPLE TIMES. HOSPITALIZATION WAS ALSO RELATED TO A NON-DIABETES RELATED ISSUES. CUSTOMER WAS DISCHARGE WITH ELEVATED BG RESOLVED THE FIRST WEEK OF APRIL (CUSTOMER WAS UNSURE OF EXACT DATE). CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY AND REPORTEDLY RECEIVED MORE PUMP TRAINING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466469 T:SLIM G5 SYSTEM CONTINUOUS GLUCOSE MONITOR OYC TANDEM DIABETES CARE 1000096

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R INSULIN: HUMALOG, INFUSION SET: AUTOSOFT 90