BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2081523 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00956
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 23, 2011
    Report Date
    March 14, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 SHE HAD AN INCIDENT WHERE SHE TRIED TO INSERT THE INFUSION SET CANNULA INTO HER BODY AND THE CANNULA CRIMPED BEFORE IT WENT IN. PT STATED SHE NOTICED IT WASN'T GOING IN SO SHE GOT ANOTHER INFUSION HEADSET AND THREW THAT ONE AWAY. PT REPORTED THE INFUSION SET CANNULA WAS BENT IN THE MIDDLE AT A 45 DEGREE ANGLE AND FORMED AN "L" SHAPE. PT STATED THE INCIDENT OCCURRED ONCE. PT REPORTED SHE FIRST NOTICED SHE WAS HAVING DIFFICULTY INSERTING THE INFUSION SET AND THE NOTICED THE CANNULA WAS BENT. PT STATED SHE REMOVED IT AND DISCARDED IT. PT REPORTED SHE DIDN'T NOTICE ANY LEAKS OF INSULIN. PT INSERTS THE INFUSION SETS MANUALLY. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX042

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR INSULIN| INSULIN INFUSION PUMP