BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    MDR report key: 3983336 · Received July 2, 2014

    Report

    Report Number
    3007981285-2014-01717
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    PMA / PMN Number
    K111210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. SHOULD NEW INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE T SLIM USER GUIDE INDICATES THE PUMP IS TO BE USED WITH INDIVIDUALS 12 YEARS OF AGE AND GREATER, PATIENT IS (B)(6).

    Description of Event or Problem · 1

    RECEIVED INFORMATION STATING THAT CUSTOMER RECEIVED AN ALARM THAT STOPPED ALL INSULIN DELIVERY. THE CONTACT WAS NOT SURE WHAT ALARM HAD OCCURRED ON THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387497 TANDEM T:SLIM INSULIN DELIVERY SYSTEM INSULIN PUMP LZG TANDEM DIABETES CARE INC. 004628

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR