BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070389 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01044
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    February 11, 2011
    Report Date
    March 25, 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
    AL, 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 THE INFUSION CANNULAS BENT DURING INSERTION. THIS OCCURRED TWO TIMES ON (B)(6) 2011 AND THEN THREE TIMES ON (B)(6) 2011. INFUSION HEADSETS WERE INSERTED MANUALLY, AND PT REPORTED THE CANNULAS BENT WHEN SHE REMOVED THE INSERTION NEEDLE AFTER INSERTION. THERE WAS NO INSULIN LEAKAGE. NO PHYSIOLOGICAL EFFECTS WERE EXPERIENCED. NOTHING ELSE UNUSUAL WAS NOTED WHEN USING THE INFUSION SETS. ALLEGED INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED FOR EVAL. PT WILL CONTACT HER SUPPLIER FOR REPLACEMENT PRODUCT. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX175

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR INSULIN| INSULIN INFUSION DEVICE