BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2110281 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01418
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    April 23, 2011
    Report Date
    April 23, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED BY EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HAVING DIFFICULTY INSERTING THE INFUSION SETS. PT STATED HE DID NOT HAVE ANY PREPARATION ISSUES AND NO LEAKING ISSUES. PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE READINGS AS HIGH AS 500 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 90-120 MG/DL. PT STATED, HE CHANGED HIS INFUSION SET AND TRIED TO BOLUS TO BRING HIS BLOOD GLUCOSE READINGS BACK DOWN. PT REPORTED, THE INFUSION SET CANNULA HAD MULTIPLE BENDS IN IT UPON REMOVAL. PT MANUALLY INSERTS THE INFUSION SETS. PT STATED, HE HAS HAD THE BENDING ISSUE TWICE IN THE LAST WEEK. PT REPORTED, HE NOTICED THE ISSUE WITH WITHIN THE NEXT FEW HOURS AFTER INSERTING A NEW INFUSION SET. PT DISCARDED THE ALLEGED INFUSION SETS. ON CALL BACK ON (B)(6) 2011, PT REPORTED, HIS BLOOD GLUCOSE LEVELS HAVE RETURNED TO NORMAL RANGE. 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 GWX113

    Patients

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