BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 6092938 · Received November 10, 2016

    Report

    Report Number
    3007981285-2016-18205
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 21, 2016
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 160 MG/DL. A SYSTEM CHECK WAS PERFORMED AND THE INSULIN EXITING FROM THE CARTRIDGE TUBING APPEARED TO BE "GELLED". THE CUSTOMER STATED THAT THE VIAL OF INSULIN APPEARED TO BE CLOUDY AND THAT A NEW VIAL WOULD BE USED TO LOAD NEW SUPPLIES ONTO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743777 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE 004628 M016299

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR INFUSION SET: SIHOUETTE, INSULIN: NOVOLOG