BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2063324 · Received April 11, 2011

    Report

    Report Number
    2183996-2011-00915
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    January 18, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1489-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT REPORTED ELEVATED BLOOD GLUCOSE IN THE 300 MG/DL RANGE DUE TO BENT INFUSION CANNULAS. HIS INFUSION SITES HAVE ALSO BEEN TENDER AND SORE. NORMAL BLOOD GLUCOSE IS APPROXIMATELY 160 MG/DL, AND PATIENT BOLUSES OR CHANGES THE INFUSION SITE TO DECREASE BLOOD GLUCOSE. THERE WERE NO ISSUES WITH THE PREPARATION, INSERTION, OR REMOVAL OF THE INFUSION SET. ON ONE OCCASION, THE INFUSION SITE LEAKED INSULIN. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS, AND THE ISSUES WERE NOTICED APPROXIMATELY 2.5 DAYS AFTER INSERTION. THIS HAS BEEN AN ONGOING CONCERN SINCE PATIENT STARTED THIS TYPE OF INFUSION SET 6-8 WEEKS AGO. NO PRODUCT WAS REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX064

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR INSULIN INFUSION DEVICE| INSULIN