BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4223216 · Received October 27, 2014

    Report

    Report Number
    3007981285-2014-10586
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 29, 2014
    Report Date
    September 30, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM. REPORTEDLY CUSTOMER'S BLOOD GLUCOSE LEVEL WAS IMPACTED (ELEVATED). CUSTOMER REVERTED TO ALTERNATE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681079 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M002509

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other DISENTRONIC TENDER| INFUSION SET: INSET, INSET 30| INSULIN: HUMALOG