BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6018710 · Received October 11, 2016

    Report

    Report Number
    3007981285-2016-13499
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 20, 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 MINIMUM FILL MESSAGE AFTER LOADING A CARTRIDGE WITH INSULIN. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH 200 UNITS OF INSULIN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 228 MG/DL, WHICH WAS ADDRESSED WITH A BOLUS. THE CUSTOMER WAS ABLE TO ADD ADDITIONAL INSULIN TO THE CARTRIDGE AND SUCCESSFULLY COMPLETE THE LOAD PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667636 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR