BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4100757 · Received September 12, 2014

    Report

    Report Number
    3007981285-2014-08030
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNING FOR EVAL. SHOULD NEW INFO BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED. T:SLIM USER GUIDE INDICATES, PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PT IS (B)(6) YEARS OLD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS (350 MG/DL), AND MODERATE KETONES. CUSTOMER IS (B)(6) YEARS OLD AND HAS A RESPIRATORY ILLNESS. SHE RECEIVED ON UNIT OF INSULIN THROUGH MANUAL INJECTION AND HER PLACEMENT SITE WAS CHANGED TO STABILIZE HER BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565161 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other