BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NONE

    MDR report key: 3983417 · Received July 7, 2014

    Report

    Report Number
    3007981285-2014-01920
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 3, 2014
    Manufacturer
    TANDEM DIABETES CARE INC.
    Product Code
    LZG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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.

    Description of Event or Problem · 1

    RECEIVED INFO STATING CUSTOMER HAS BEEN EXPERIENCING MULTIPLE OCCLUSION ALARMS. REPORTEDLY, CUSTOMER CHANGED OUT CARTRIDGE AND REPEATED THE FILL TUBING PROCESS WITHOUT THE TUBING ATTACHED AND WAS ABLE TO SEE DROPS OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395143 NONE LZG TANDEM DIABETES CARE INC. 004628 M002857

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR