BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM G4 SYSTEM

    MDR report key: 9447511 · Received December 10, 2019

    Report

    Report Number
    3013756811-2019-87683
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 10, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    OYC
    UDI-DI
    852162004439
    PMA / PMN Number
    P140015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE USB PORT WAS DAMAGED AND THE PUMP COULD NOT BE CHARGED PROPERLY WITHOUT THE CUSTOMER MANEUVERING THE CABLE INTO THE CHARGING PORT AT A CERTAIN ANGLE. THE CUSTOMER'S BLOOD GLUCOSE WAS APPROXIMATELY 130-300 MG/DL. REPORTEDLY, THE CUSTOMER REVERTED TO MANUAL INJECTIONS FOR INSULIN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238153 T:SLIM G4 SYSTEM INSULIN PUMP OYC TANDEM DIABETES CARE 4628-003 852162004439

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR