BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® INSIGHT TENDERLINK INFUSION SET

    MDR report key: 5320068 · Received December 22, 2015

    Report

    Report Number
    3011393376-2015-05864
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Date of Event
    November 26, 2015
    Report Date
    July 25, 2025
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE FOLLOWING CORRECTION: TWO LOT NUMBERS WERE RETURNED FOR EVALUATION, LOT 1125249 AND LOT 1121511. ADDITIONAL INFORMATION WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE SELF-ADHESIVE OF SEVERAL INFUSION SETS HAS NOT ADHERED CORRECTLY. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844556 ACCU-CHEK ® INSIGHT TENDERLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. 1125249

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female