BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2013052 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00349
    Event Type
    Malfunction
    Date Received
    March 4, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED INSULIN HAS LEAKED FROM HER INFUSION SITES AND THIS HAS CAUSED ELEVATED BLOOD GLUCOSE. THE INFUSION CANNULAS HAVE NOT BEEN BENT. PT HAS NOTICED THE LEAK WHEN THE INFUSION SET ADHESIVE BECOMES DAMP AND SHE CAN SMELL INSULIN. PT WILL ALSO PRESS ON HER INFUSION SITE AFTER THE HEADSET IS REMOVED, AND INSULIN WILL COME OUT. BLOOD GLUCOSE HAS ELEVATED TO THE 400-500 MG/DL RANGE, AND HER TARGET BLOOD GLUCOSE IS UNDER 120 MG/DL. BLOOD GLUCOSE WAS 113 MG/DL ON THE MORNING OF THE REPORT. PT TYPICALLY NOTICES THE LEAK ON THE SECOND OR THIRD DAY OF USING THE SITE. AN INSERTION DEVICE IS USED TO INSERT THE HEADSETS. THIS CONCERN HAS BEEN ONGOING SINCE PT STARTED THIS NEW TYPE OF INFUSION SET. PT REPORTED HER BLOOD GLUCOSE RETURNED TO NORMAL AFTER CHANGING THE INFUSION SITE. INFUSION SETS WERE DISCARDED AND NOT REQUESTED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION DEVICE| INSULIN