BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 7168813 · Received January 5, 2018

    Report

    Report Number
    3007981285-2018-00521
    Event Type
    Malfunction
    Date Received
    January 5, 2018
    Date of Event
    December 1, 2017
    Report Date
    January 5, 2018
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INSULIN GAUGE DISPLAYED MULTIPLE, INTERMITTENT INACCURATE FILL ESTIMATES. REPORTEDLY, THE CARTRIDGES WERE FILLED WITH 240-280 UNITS OF INSULIN. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IN THE 200'S (MG/DL). AS THE CUSTOMER WAS NOT EXPERIENCING AN ISSUE AT THE TIME OF THE REPORTED EVENT, TANDEM TECHNICAL SUPPORT WAS UNABLE TO PERFORM TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12079 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR