BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4100785 · Received September 12, 2014

    Report

    Report Number
    3007981285-2014-08038
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 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
    CA, US
    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. PER TANDEM'S USER GUIDE, INSULIN SHOULD BE AT ROOM TEMPERATURE BEFORE FILLING CARTRIDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD EXPERIENCED HIGH BLOOD GLUCOSE LEVELS (340 MG/DL). CUSTOMER ATE FOOD AND TOOK A CORRECTIVE BOLUS TO STABILIZE HIS BLOOD GLUCOSE LEVELS. THE CUSTOMER REPORTEDLY DOES NOT LOAD HIS INSULIN ROOM TEMPERATURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565275 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003661

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other