BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 6190859 · Received December 20, 2016

    Report

    Report Number
    3011393376-2016-07869
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    December 2, 2016
    Report Date
    April 6, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED OUTSIDE OF THE UNITED STATES WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION SET WAS LEAKING AT THE HEADSET. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839609 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. 5134300

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR