BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® RAPID-D INFUSION SET

    MDR report key: 6190821 · Received December 20, 2016

    Report

    Report Number
    3011393376-2016-07864
    Event Type
    Malfunction
    Date Received
    December 20, 2016
    Date of Event
    August 15, 2016
    Report Date
    May 3, 2017
    Manufacturer
    ROCHE DIABETES CARE, INC.
    Product Code
    FPA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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

    CALLER ALLEGES INFUSION SET HAS LEAKED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838759 ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIABETES CARE, INC. 32095116

    Patients

    Seq Age Sex Outcome Treatment
    1