BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT FLEX

    MDR report key: 7790369 · Received August 16, 2018

    Report

    Report Number
    3011393376-2018-03431
    Event Type
    Malfunction
    Date Received
    August 16, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 17, 2018
    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. IT WAS REPORTED THAT THE PATIENT HAS 3 DIFFERENT BOXES OF INFUSION SETS (LOTS 1217256, 1223242, AND 1220711) THE CALLER IS UNABLE TO RECALL WHICH LOT # PRESENTED THE PROBLEM OF THE ADHESIVE NOT STICKING.

    Description of Event or Problem · 1

    THE CALLER REPORTED THE ADHESIVE FROM THE INFUSION SETS WERE NOT STICKING TO THE PATIENT'S SKIN. THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE LEVELS. IT WAS UNKNOWN WHAT BATCH THE ISSUE OCCURRED WITH (1217256, 1223242, 1220711). 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
    631961 ACCU-CHEK ® INSIGHT FLEX SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR