BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2143632 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01585
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 12, 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 THAT SHE EXPERIENCED CONCERNS WHILE USING THE INFUSION SETS. SHE HAD DIFFICULTY PRESSING THE BLUE RELEASE BUTTON AND INSERTING THE INFUSION SETS. THERE WAS OCCASIONALLY INSULIN LEAKAGE AT HER INFUSION SITES. SHE DID NOT EXPERIENCE ANY PHYSIOLOGICAL EFFECTS. THERE WERE MULTIPLE BENDS IN THE CANNULA AFTER THE HEADSETS WERE REMOVED. HEADSETS WERE INSERTED MANUALLY AND WITH THE INSERTION DEVICE, AND PT COULD TELL THERE WERE ISSUES WITHIN 5 MINUTES OF INSERTION. THERE WERE NO OTHER OBSERVATIONS WHILE USING THE INFUSION SETS. ALLEGED INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED FOR EVAL. THE PT DID NOT REQUIRE TREATMENT 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR INSULIN INFUSION DEVICE| INSULIN