BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK/ULTRAFLEX TRANSFER SET

    MDR report key: 3212348 · Received July 9, 2013

    Report

    Report Number
    2183996-2013-01227
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    July 4, 2013
    Report Date
    October 1, 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
    BR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION THE COMPLAINT DESCRIBING A LEAKY ON THE TRANSFER SET CANNOT BE VERIFIED, THE MATERIAL MEETS PRODUCT SPECIFICATIONS. RESULT NO SAMPLE WAS RECEIVED FOR EXAMINATION. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE PROBLEM MENTIONED BY THE CUSTOMER COULD NOT BE REPRODUCED. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THIS 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 A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT'S MOTHER REPORTED THIS IS THE 2ND INFUSION SET FOR THE INFUSION DEVICE THAT IS LEAKING PERSISTENTLY. NO FURTHER INFORMATION IS AVAILABLE. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313058 ACCU-CHEK FLEXLINK/ULTRAFLEX TRANSFER SET SUBCUTANEOUS INFUSION SET FPA ROCHE HEALTH SOLUTIONS, INC 00700006963 00227214

    Patients

    Seq Age Sex Outcome Treatment
    1 014 YR