BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® RAPID-D INFUSION SET

    MDR report key: 3840381 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03868
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEAK OCCURRING BETWEEN THE CANNULA AND HEADSET WHEN THE PATIENT ADMINISTERED BOLUSES. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318632 ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 32443263

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR