BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4100784 · Received September 12, 2014

    Report

    Report Number
    3007981285-2014-08036
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 17, 2014
    Report Date
    August 31, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS (356 MG/DL), AND KETONES. CUSTOMER RECEIVED CORRECTION BOLUSES THROUGH A SYRINGE, AND INCREASED HIS BASAL RATES AND RATIOS TO STABILIZE HIS BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565001 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003563

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Other