BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8251257 · Received January 15, 2019

    Report

    Report Number
    3013756811-2019-02434
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    October 1, 2018
    Report Date
    January 15, 2019
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PUMP SERIAL NUMBERS: (B)(4). CARTRIDGE LOT NUMBER: M020792.

    Description of Event or Problem · 1

    QUARTERLY SUMMARY REPORT FOR ALLEGED ISSUES DURING THE LOAD FILL TUBING SEQUENCE: IT WAS REPORTED THAT INSULIN WAS NOT EXITING THE TUBING OR INSULIN DROPS WERE EXITING SLOWER THAN NORMAL. THE ISSUE WAS RESOLVED BY USING NEW SUPPLIES (CARTRIDGE AND/OR INFUSION SET). THERE WAS NO ADVERSE EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39827 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1