BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 8156156 · Received December 12, 2018

    Report

    Report Number
    3013756811-2018-45815
    Event Type
    Malfunction
    Date Received
    December 12, 2018
    Date of Event
    December 10, 2018
    Report Date
    December 12, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    852162004439
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION HAS BEEN COMPLETED. BASED ON THE ANALYSIS, NO FAILURES WERE FOUND IN REGARDS TO THE ISSUES REPORTED; HOWEVER, DIFFERENT ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TOUCHSCREEN WAS UNRESPONSIVE. SUBSEQUENTLY, IT WAS REPORTED THAT THE "PREPARING FOR FILL" NOTIFICATION BECAME FROZEN ON THE PUMP SCREEN AND THE CUSTOMER WAS UNABLE TO CLEAR IT. ADDITIONALLY, IT WAS REPORTED THAT A CARTRIDGE ALARM (ALARM 01) OCCURRED. A CARTRIDGE CHANGE WAS PERFORMED RESOLVING THE ALARM. ADDITIONALLY, IT WAS REPORTED THAT A MINIMUM FILL NOTIFICATION WAS RECEIVED. REPORTEDLY, THE CARTRIDGE HAD BEEN FILLED WITH 300 UNITS OF INSULIN. CUSTOMER'S BLOOD GLUCOSE LEVEL DURING THESE EVENTS RANGED BETWEEN 230-350 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994128 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 852162004439

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR