BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT FLEX INFUSION SET

    MDR report key: 6445171 · Received March 29, 2017

    Report

    Report Number
    3011393376-2017-01869
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    March 4, 2017
    Report Date
    March 29, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 SELF-ADHESIVE OF THE INFUSION SET WAS WET WITH INSULIN THAT WAS INTENDED TO BE DELIVERED TO THE PATIENT. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. NO ADVERSE EVENT REPORTED. THE CUSTOMER WAS UNABLE TO DETERMINE WHICH LOT NUMBER OF INFUSION SETS WERE IN USE AT THE TIME. THE INCIDENT COULD HAVE OCCURRED WITH LOT NUMBER (1170251) OR (1140010). THE INFUSION SET WAS DISCARDED; THEREFORE, NO PRODUCT COULD BE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223933 ACCU-CHEK ® INSIGHT FLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR UNKNOWN INSULIN