BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 5123545 · Received October 2, 2015

    Report

    Report Number
    3007981285-2015-54432
    Event Type
    Malfunction
    Date Received
    October 2, 2015
    Date of Event
    September 4, 2015
    Report Date
    September 4, 2015
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING 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 WHILE THE CUSTOMER WAS ATTEMPTING TO REMOVE THE PUMP CASE, THE PATIENT LINE SEPARATED FROM THE CARTRIDGE. 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
    652711 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR