BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6831899 · Received August 30, 2017

    Report

    Report Number
    3007981285-2017-24409
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    August 7, 2017
    Report Date
    August 30, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 THE CUSTOMER DID NOT OBSERVE INSULIN DRIPPING OUT OF THE INFUSION TUBING DURING THE LOAD FILL TUBING SEQUENCE. REPORTEDLY, AFTER FILLING THE TUBING WITH 30 UNITS, A CARTRIDGE CHANGE WAS PERFORMED. IT WAS REPORTED THAT THE INSULIN WAS LOADED INTO THE CARTRIDGE WITHOUT PERFORMING THE AIR REMOVAL TECHNIQUE. THEN, WHEN ATTEMPTING TO FILL THE CARTRIDGE WITH INSULIN, THE CUSTOMER EXPERIENCED RESISTANCE. THE CUSTOMER CHANGED ALL OF THE SUPPLIES ON THE PUMP, AND COMPLETED THE LOAD PROCESS SUCCESSFULLY AND RESUMED INSULIN DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL RANGED FROM 243-306 (MG/DL), AND WAS ADDRESSED WITH MULTIPLE, CORRECTION BOLUSES. TROUBLESHOOTING WAS PERFORMED WITH TANDEM TECHNICAL SUPPORT AND UPON REVIEW OF THE PUMP LOGS, IT WAS FOUND THAT THE CUSTOMER'S INSULIN DURATION WAS SET FOR 5 HOURS AND MAXIMUM BOLUS SETTINGS WAS SET FOR 10 UNITS. HOWEVER, ON THE PREVIOUS PUMP THE INSULIN DURATION WAS SET TO 4 HOURS AND MAXIMUM BOLUS WAS FOR 20 UNITS. THE CUSTOMER REPORTED THAT THE SETTINGS HAD BEEN PROGRAMMED BY THE HEALTH CARE PROVIDER (HCP) AND CONTACTED HCP TO ENSURE THE SETTINGS WERE ACCURATE. DURING A FOLLOW-UP CALL ON (B)(6) 2017, IT WAS CONFIRMED THAT THE CUSTOMER'S BG LEVEL RETURNED TO TARGET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612048 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 M020005

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other INSULIN: HUMALOG, INFUSION SET: INSET, T:90