BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4840179 · Received June 11, 2015

    Report

    Report Number
    3007981285-2015-33688
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    April 26, 2015
    Report Date
    May 15, 2015
    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 EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL FORM WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE THIRD DAY OF THE CARTRIDGE BEING IN USE THE CUSTOMER EXPERIENCES ELEVATED BLOOD GLUCOSE LEVELS, AND AFTER THE CARTRIDGE IS CHANGED THE CUSTOMER EXPERIENCES LOW BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382590 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other