BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE

    MDR report key: 6175133 · Received December 15, 2016

    Report

    Report Number
    3011393376-2016-07777
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Date of Event
    October 26, 2016
    Report Date
    January 11, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    KZH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INSERTION DEVICE EJECTED THE INFUSION SET UNINTENTIONALLY. NO ADVERSE EVENT REPORTED. THE DEVICE LOT NUMBER WAS NOT PROVIDED. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829046 ACCU-CHEK ® LINKASSIST PLUS INSERTION DEVICE SPRING LOADED INSERTION DEVICE KZH ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR