BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4180314 · Received October 15, 2014

    Report

    Report Number
    3007981285-2014-09537
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 21, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM PUMP USER GUIDE CAUTIONS FROM FILLING A CARTRIDGE UNTIL PROMPTED BY INSTRUCTIONS ON THE PUMP SCREEN. THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW RELEVANT INFO BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    RECEIVED INFO STATING THAT THE CUSTOMER'S FILL ESTIMATE WAS INACCURATE. REPORTEDLY, THE CARTRIDGE WAS FILLED WITH MORE INSULIN DURING FILL TUBING. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653069 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR