BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4840167 · Received June 11, 2015

    Report

    Report Number
    3007981285-2015-34051
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 17, 2015
    Report Date
    May 18, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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 THE CUSTOMER HAD ELEVATED BLOOD GLUCOSE LEVELS (600 MG/DL). REPORTEDLY, THE CARTRIDGE WAS LEAKING. THE CARTRIDGE AND INFUSION SET WAS SUCCESSFULLY CHANGED, AND INSULIN DELIVERY WAS RESUMED. CUSTOMER DELIVERED BOLUSES AND MANUAL INJECTIONS TO STABILIZE HER BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382539 TANDEM T:SLIM INSULIN DELIVERY SYSTEM LZG TANDEM DIABETES CARE INC. 004628 M014566

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other INSULIN: NOVOLOG