BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® RAPID-D INFUSION SET

    MDR report key: 3830386 · Received May 23, 2014

    Report

    Report Number
    1823260-2014-03664
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THE INFUSION SETS HAVE LEAKED INSULIN AND THIS HAS RESULTED IN ELEVATED BLOOD GLUCOSE OF APPROXIMATELY 350 MG/DL. THE INFUSION DEVICE HAS ALSO DISPLAYED E4 OCCLUSION ERRORS. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307806 ACCU-CHEK ® RAPID-D INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 32371493

    Patients

    Seq Age Sex Outcome Treatment
    1 022 YR