BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4121130 · Received September 24, 2014

    Report

    Report Number
    3007981285-2014-09058
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 15, 2014
    Manufacturer
    TANDEM DIABETES CARE, INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS (227-363 MG/DL). CUSTOMER WAS PREVIOUSLY HAVING ISSUES WITH HER INFUSION SET COMING LOOSE. SHE USES NOVOLOG AND CHANGES HER CARTRIDGE ABOUT EVERY 4-5 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594703 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE, INC. 004628 M002445

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other INFUSION SET: CLEO 90