BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T: SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4203116 · Received September 18, 2014

    Report

    Report Number
    3007981285-2014-07700
    Event Type
    Malfunction
    Date Received
    September 18, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 22, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    CUSTOMER WAS PROMPTED TO ADD A MINIMUM OF 50 UNITS TO THEIR PUMP'S CARTRIDGE AFTER FILLING A CARTRIDGE. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578851 TANDEM T: SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M003339

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR