BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4223190 · Received October 27, 2014

    Report

    Report Number
    3007981285-2014-10486
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 30, 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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED AN OCCLUSION ALARM. CUSTOMER DISCONNECTED THE INFUSION SET TUBING AT THE LUER LOCK AND FOUND THAT THE INSULIN HAD A GEL-LIKE CONSISTENCY. REPORTEDLY, CUSTOMER'S BLOOD GLUCOSE LEVEL WAS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681125 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M001849

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other INFUSION SET: INSET| INSULIN: HUMALOG