BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8518052 · Received April 16, 2019

    Report

    Report Number
    3013756811-2019-01711
    Event Type
    Malfunction
    Date Received
    April 16, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 16, 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

    POSSIBLE USE ERRORS: USING COLD INSULIN AND OVERFILLING THE CARTRIDGE. PER TANDEM'S T:SLIM USER GUIDE: "INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING CARTRIDGE" AND "THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0 ML) OF INSULIN." PUMP SERIAL NUMBERS:(B)(4). CARTRIDGE LOT NUMBERS: M018274, M104343, M020547, M112625, M110288.

    Description of Event or Problem · 1

    QUARTERLY SUMMARY REPORT FOR ALLEGED INSULIN GAUGE ISSUES: IT WAS REPORTED THAT THE INSULIN GAUGE WAS INACCURATE OR A MINIMUM FILL NOTIFICATION WAS RECEIVED AFTER THE CARTRIDGE WAS FILLED WITH A SUFFICIENT AMOUNT OF INSULIN. THE ISSUE WAS RESOLVED BY LOADING A NEW CARTRIDGE OR REVERTING TO AN ALTERNATE METHOD OF INSULIN THERAPY. THERE WAS NO ADVERSE IMPACT TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310499 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 INFUSION SET, INSULIN