BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 8516419 · Received April 15, 2019

    Report

    Report Number
    3013756811-2019-09740
    Event Type
    Malfunction
    Date Received
    April 15, 2019
    Date of Event
    January 1, 2019
    Report Date
    April 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

    POSSIBLE USE ERRORS: OVERFILLING THE CARTRIDGE BAG. PER TANDEM'S T:SLIM USER GUIDE: "THE SINGLE-USE DISPOSABLE CARTRIDGE CAN HOLD UP TO 300 UNITS (3.0 ML) OF INSULIN." PUMP SERIAL NUMBERS: (B)(4). CARTRIDGE LOT NUMBER: M140162.

    Description of Event or Problem · 1

    QUARTERLY SUMMARY REPORT FOR ALLEGED CARTRIDGE ALARM 1: IT WAS REPORTED THAT A CARTRIDGE ALARM 1 OCCURRED DURING THE LOAD SEQUENCE OR DURING BASAL/BOLUS DELIVERY. THE ISSUE WAS RESOLVED BY LOADING A NEW CARTRIDGE AND/OR INFUSION SET, OR THE USER REVERTED TO AN ALTERNATE METHOD OF INSULIN DELIVERY. THERE WAS NO ADVERSE IMPACT TO THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308558 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1