BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2051378 · Received April 4, 2011

    Report

    Report Number
    2183996-2011-00795
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    January 11, 2011
    Report Date
    March 6, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 HAVING TROUBLE WITH THE INFUSION SET CANNULA BENDING. PT STATED SOMETIMES UPON INSERTING THE INFUSION SET, THE INFUSION SET CANNULA WOULD BEND. PT REPORTED HE DID NOT HAVE ANY LEAKING. PT STATED HIS BLOOD GLUCOSE READINGS WERE IN THE 300-400 MG/DL RANGE. PT REPORTED HE WOULD CHANGE THE INFUSION SET AND HIS BLOOD GLUCOSE WOULD GO DOWN. PT'S NORMAL BLOOD GLUCOSE RANGE IS 80-150 MG/DL. PT STATED HE WOULD NOTICE WHEN HE REMOVED THE INFUSION SET THAT THE CANNULA WAS BENT. PT INSERTS THE INFUSION SETS USING THE INSERTION ASSIST PLUS DEVICE. PT REPORTED HE WOULD NOTICE THE CONCERN WITHIN 1-1.5 DAYS AFTER INSERTING THE INFUSION SET. PT REPORTED EXPERIENCING THE ISSUE MORE THAN ONCE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REPLACEMENT INFUSION SETS WERE SENT; 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 GWX075

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR INSULIN INFUSION PUMP| INSULIN