BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT FLEX

    MDR report key: 8047800 · Received November 7, 2018

    Report

    Report Number
    3011393376-2018-04631
    Event Type
    Malfunction
    Date Received
    November 7, 2018
    Date of Event
    October 10, 2018
    Report Date
    January 2, 2019
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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), IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CANNULA HOUSING OF THE INFUSION SET UNLOCKS UNINTENTIONALLY. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. THE CALLER ALLEGED THAT THEY HAVE EXPERIENCED THIS ISSUE BEFORE, BUT HAVE NOTICED IT INCREASINGLY WITH THE MOST RECENT BATCH (1223256). NO ADVERSE EVENT WAS REPORTED. THE INFUSION SETS WERE REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888990 ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. 1230828

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR