BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 4181278 · Received October 14, 2014

    Report

    Report Number
    3007981285-2014-09427
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 20, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVAL. SHOULD NEW RELEVANT INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A LARGER THAN NORMAL CORRECTION BOLUS REQUEST. DURING TROUBLESHOOTING WITH TANDEM TECHNICAL SUPPORT, THE SETTING WAS CONFIRMED TO BE 1UN:4MGDL. CUSTOMER INDICATED THAT THE SETTING SHOULD BE 1UN:4MGDL. CUSTOMER STATED THAT THE HEALTH CARE PROVIDER HAD CHANGED SETTINGS IN THE PUMP AND MAY HAVE CHANGED IT ACCIDENTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649005 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR