BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6031884 · Received October 15, 2016

    Report

    Report Number
    3007981285-2016-14018
    Event Type
    Malfunction
    Date Received
    October 15, 2016
    Date of Event
    September 25, 2016
    Report Date
    September 25, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A CARTRIDGE CHANGE ERROR MESSAGE WHILE ATTEMPTING TO LOAD A NEW CARTRIDGE. REPORTEDLY, THE CUSTOMER DID NOT INSTALL THE CARTRIDGE WHEN INSTRUCTED TO. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. THE CUSTOMER SUCCESSFULLY LOADED A NEW CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683757 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR