BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER LINK

    MDR report key: 2913480 · Received December 21, 2012

    Report

    Report Number
    2183996-2012-02034
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 14, 2012
    Report Date
    March 21, 2013
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED. A VISUAL INSPECTION AND TESTS FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED UNUSED INFUSION SETS, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS. THE REFERENCE SAMPLES WERE VISUALLY INSPECTED AND TESTED FOR FLOW AND LEAK, AND ALL TEST RESULTS WERE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    PATIENT REPORTED 6 INFUSION SETS FROM THE SAME BOX HAVE LEAKED INSULIN, AND THIS HAS RESULTED IN HYPERGLYCEMIA OF 200 MG/DL. THE INFUSION SET ADHESIVE HAS BECOME WET WITH INSULIN AND LOOSENED, AND SHE HAS BEEN ABLE TO SMELL INSULIN. THIS HAS OCCURRED ON THE SECOND DAY OF USE, TYPICALLY WHEN LARGER AMOUNTS OF INSULIN WERE DELIVERED. PT REPORTED THE INFUSION NEEDLE WAS INSERTED WELL. THE INFUSION SETS WERE REQUESTED FOR EVAL. SHE DID NOT REQUIRE TREATMENT FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER LINK FPA ROCHE INSULIN DELIVERY SYSTEMS INC. 00700006953 655418

    Patients

    Seq Age Sex Outcome Treatment
    1 RELATED ACCESSORIES| INSULIN INFUSION PUMP| INSULIN