BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4240058 · Received October 29, 2014

    Report

    Report Number
    3007981285-2014-11086
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    October 4, 2014
    Report Date
    October 4, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A FOLLOW UP SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFORMATION REGARDING AIR BUBBLES IN THE CARTRIDGE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS NOT IMPACTED. CUSTOMER REPORTED THEY WOULD CHANGE THE CARTRIDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693580 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M001656

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR