BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2030671 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00577
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 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
    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 HAVING A BENT INFUSION SET CANNULA. PT CALLED REGARDING THE INFUSION SET RECALL. PT STATED, SHE DOES NOT HAVE ANY INFUSION SETS LEFT. PT REPORTED HER BLOOD GLUCOSE HAD BEEN ELEVATED IN THE 200¿S MG/DL. PT¿S NORMAL BLOOD GLUCOSE LEVEL IS AROUND 150 MG/DL. PT STATED, SHE TREATED HERSELF BY BOLUSING AND IF HER BLOOD GLUCOSE DIDN¿T COME DOWN AFTER 2 BOLUSES SHE WOULD CHANGE THE INFUSION SITE. PT REPORTED, SHE ONLY NOTICED ONE TIME WHEN AN INFUSION SET CANNULA WAS BENT. PT STATED, THERE WAS NO LEAKING. PT HAS DISPOSED OF THE ALLEGED INFUSION SET. EDUCATED PT ON ALTERNATIVE TYPES OF INFUSION SETS AVAILABLE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR INSULIN| INSULIN INFUSION PUMP