BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® FLEXLINK INFUSION SET

    MDR report key: 3082639 · Received April 29, 2013

    Report

    Report Number
    2183996-2013-00756
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 29, 2013
    Manufacturer
    UNOMEDICAL DEVICES S.A. DE C.V.
    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 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 COMPLAINT DESCRIBING A LEAK ON THE HEADSET CANNOT BE VERIFIED. THE HEADSET MEETS PRODUCT SPECIFICATIONS. THE THREE UNUSED INFUSION SETS WERE VISUALLY INSPECTED AND TESTS FOR FLOW AND TIGHTNESS WERE PERFORMED. ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT REPORTED THE INFUSION SETS HAVE LEAKED INSULIN BETWEEN THE CANNULA AND SELF-ADHESIVE FOR 2-3 WEEKS. HER BLOOD GLUCOSE HAS ELEVATED TO 300 MG/DL, AND SHE'S DELIVERED INSULIN VIA THE INFUSION DEVICE AS TREATMENT. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SETS WERE REQUESTED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185751 ACCU-CHEK ® FLEXLINK INFUSION SET SUBCUTANEOUS INFUSION SET FPA UNOMEDICAL DEVICES S.A. DE C.V. 00700008650 0229502

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR