BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2030644 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00584
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 9, 2011
    Report Date
    March 2, 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
    FL, 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 HEADACHES AND ABDOMINAL PAIN. PT STATED HER BLOOD GLUCOSE LEVEL IS 261 MG/DL. PT¿S NORMAL BLOOD GLUCOSE RANGE IS 98-140 MG/DL. PT REPORTED, SHE HAS NEVER HAD ANY CONCERNS WITH A BENT INFUSION SET CANNULA. PT STATED, SHE NOTICED LEAKING AT THE INFUSION SITE. PT REPORTED WHEN SHE GOES TO THE RESTROOM, SHE CHECKS THE INFUSION SITE AND THE ADHESIVE WAS WET WITH INSULIN. PT STATED, SHE IS INSERTING THE INFUSION SET WITH THE INSERTION ASSIST PLUS DEVICE. PT REPORTED, THE INFUSION SET WAS IN USE FOR A FEW DAYS. ADVISED PT TO SPEAK TO HER DOCTOR ABOUT HER CONCERNS WITH THE HEADACHE. PT DISCARDED THE ALLEGED INFUSION SET. 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 GWX075

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN| INSULIN INFUSION PUMP