BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® ULTRAFLEX INFUSION SET

    MDR report key: 3964914 · Received July 29, 2014

    Report

    Report Number
    1823260-2014-05638
    Event Type
    Malfunction
    Date Received
    July 29, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    K122686
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. CASE WITH PATIENT IDENTIFIER (B)(6) IS RELATED TO CASE WITH PATIENT IDENTIFIER (B)(6). PRODUCT WAS DISCARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INFUSION SET LEAKED AT THE INFUSION SITE. THE PATIENT NOTICED THE LEAK WHEN SHE FELT WETNESS AT THE INFUSION SITE. NO ADVERSE EVENT WAS REPORTED. THE INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440967 ACCU-CHEK ® ULTRAFLEX INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5046630

    Patients

    Seq Age Sex Outcome Treatment
    1