BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT FLEXLINK PLUS INFUSION SET

    MDR report key: 5802381 · Received July 18, 2016

    Report

    Report Number
    3011393376-2016-04715
    Event Type
    Malfunction
    Date Received
    July 18, 2016
    Date of Event
    September 15, 2015
    Report Date
    July 18, 2016
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    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. THIS CASE, WITH PATIENT IDENTIFIER (B)(6) (LOT NUMBER 1117616), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6) (LOT NUMBER 1111759).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION TUBING WAS LEAKING AT THE CONNECTOR OF THE INFUSION SET. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455358 ACCU-CHEK ® INSIGHT FLEXLINK PLUS INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. 1117616

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR