BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4012503 · Received August 12, 2014

    Report

    Report Number
    3007981285-2014-04733
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 13, 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
    NE, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING THE LUER LOCK BEING DISCONNECTED FROM THE INFUSION SET TUBING. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478836 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M001655

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INFUSION SET: INSET