BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6094343 · Received November 10, 2016

    Report

    Report Number
    3007981285-2016-18851
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    June 1, 2016
    Report Date
    October 20, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PATIENT

    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. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CARTRIDGE LOADING, WHEN THE AIR REMOVAL STEP WAS PERFORMED, THE CUSTOMER WAS ABLE TO REMOVE MORE AIR THAN EXPECTED FROM MULTIPLE CARTRIDGES. THE CUSTOMER CHANGED OUT THE CARTRIDGE TO A NEW CARTRIDGE AND WAS ABLE TO COMPLETE THE LOAD PROCESS SUCCESSFULLY. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744712 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M018490

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR