BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 3902235 · Received June 30, 2014

    Report

    Report Number
    1823260-2014-04755
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    March 9, 2014
    Report Date
    August 5, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    MOTHER REPORTED THE SELF-ADHESIVE ON THE INFUSION SETS IS DEFECTIVE AND THE INFUSION SETS LEAK INSULIN. THE CUSTOMER EXPERIENCED ELEVATED BLOOD GLUCOSE AS A RESULT. NO ADVERSE EVENT WAS REPORTED. THE ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379354 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA ROCHE DIAGNOSTICS NA 5037007

    Patients

    Seq Age Sex Outcome Treatment
    1