BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4852827 · Received June 17, 2015

    Report

    Report Number
    3007981285-2015-34811
    Event Type
    Malfunction
    Date Received
    June 17, 2015
    Date of Event
    May 21, 2015
    Report Date
    May 21, 2015
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S FILL ESTIMATE WAS INACCURATE AFTER LOADING A CARTRIDGE WITH INSULIN. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395391 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M015343

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR