BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK INSIGHT RAPIDLINK INFUSION SET

    MDR report key: 5247322 · Received November 24, 2015

    Report

    Report Number
    3011393376-2015-05227
    Event Type
    Malfunction
    Date Received
    November 24, 2015
    Date of Event
    October 8, 2015
    Report Date
    July 29, 2025
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE ORSIMILAR 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'S BLOOD GLUCOSE LEVEL WENT UP TO 250 MG/DL. NO ADVERSE EVENT REPORTED. THE PATIENT HAD 2 INFUSION SETS WITH LOT NUMBER 1123911 AND LOT NUMBER 1123870. THE PATIENT COULDN'T REMEMBER WHICH LOT NUMBER HAD THE INSULIN LEAK. RETURN OF THE SUSPECT DEVICE WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775676 ACCU-CHEK INSIGHT RAPIDLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU
    775677 ACCU-CHEK INSIGHT RAPIDLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Female UNKNOWN INSULIN| UNKNOWN INSULIN| UNKNOWN INSULIN