BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 6417438 · Received March 20, 2017

    Report

    Report Number
    3007981285-2017-07557
    Event Type
    Injury
    Date Received
    March 20, 2017
    Date of Event
    February 25, 2017
    Report Date
    March 20, 2017
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    PMA / PMN Number
    P140015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, THE REPORTED OCCLUSION WAS IDENTIFIED IN THE PUMP LOGS; NO FUNCTIONAL ISSUES RELATED TO THE OCCLUSION WAS IDENTIFIED DURING TESTING. THE REPORTED MALFUNCTION WAS VERIFIED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM. THE CUSTOMER CHANGED THE PUMP SUPPLIES AND THEN A MALFUNCTION 4 CODE WAS RECEIVED. THE CUSTOMER'S BLOOD GLUCOSE (BG) LEVEL WAS 240-334 MG/DL. THE CUSTOMER'S HEALTHCARE PROVIDER HAD INSTRUCTED THE CUSTOMER NOT DELIVER A CORRECTION BOLUS AS THE CUSTOMER'S BLOOD GLUCOSE DROPS TOO MUCH WHEN SHE DOES THIS. THE CUSTOMER WAS TO USE INSULIN PENS TO MANAGE DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200082 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other INSULIN: NOVOLOG, INFUSION SET: T:90