BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2011710 · Received March 4, 2011

    Report

    Report Number
    2183996-2011-00373
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 22, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 WHEN SHE PULLED OUT HER INFUSION SET, PUS BUBBLED UP WHERE THE INFUSION SET WAS INSERTED. PT STATED SHE PUT SOME ANTIBIOTIC ON IT THAT HER DOCTOR ORDERED AND IT CLEARED IT UP. PT REPORTED WHEN SHE PULLS OUT THE INFUSION SETS, SHE NOTICES THE CANNULA IS BENT. PT REQUESTED SUGGESTIONS REGARDING HER INFUSION SITE. ADVISED PT TO SPEAK WITH HER DOCTOR. ADVISED PT TO TRY A DIFFERENT SIZE CANNULA. REPLACEMENT INFUSION SETS WERE SENT; NO PRODUCT RETURNED 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 GWX049

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention INSULIN INFUSION PUMP| INSULIN