BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 3220857 · Received July 11, 2013

    Report

    Report Number
    2183996-2013-01259
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 18, 2013
    Report Date
    August 27, 2013
    Manufacturer
    ROCHE HEALTH SOLUTIONS INC
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    THE RETURNED USED TRANSFER SET WAS VISUALLY INSPECTED AND TESTED FOR FLOW AND TIGHTNESS. THE TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, IT WAS REPORTED THAT INSULIN WAS LEAKING FROM THE PATIENT'S INFUSION SET, POSSIBLY FROM THE TRANSFER SET, BUT THE PATIENT WAS NOT COMPLETELY SURE FROM WHERE THE LEAK WAS COMING. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REQUESTED TO BE RETURNED FOR PRODUCT EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321275 ACCU-CHEK FLEXLINK SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS INC 00700006963 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1