BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4200241 · Received October 22, 2014

    Report

    Report Number
    3007981285-2014-10489
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 27, 2014
    Report Date
    September 27, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE T:SLIM PUMP USER GUIDE WARNS THAT FAILING TO REMOVE AIR FROM FILLING SYRINGE AND TUBING MAY RESULT IN INACCURATE DELIVERY OF INSULIN. 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

    THE CUSTOMER RECEIVED A MESSAGE DURING THE FILL TUBING PROCESS THAT THE CARTRIDGE NEEDED A MINIMUM OF 50 UNITS OF INSULIN TO PROCEED. REPORTEDLY, THE CARTRIDGE HAD BEEN FILLED WITH 180 UNITS AND AIR BUBBLES. THERE WAS NO IMPACT TO THE CUSTOMER'S BLOOD GLUCOSE LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673715 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628 M004772

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR