BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST

    MDR report key: 5001834 · Received August 13, 2015

    Report

    Report Number
    3011393376-2015-02627
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    February 2, 2015
    Report Date
    October 27, 2015
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    KZH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). 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 INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY. NO ADVERSE EVENT WAS REPORTED. THE INSERTION DEVICE WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537212 ACCU-CHEK ® LINKASSIST SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE, INC. NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 042 YR