BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 1915652 · Received December 1, 2010

    Report

    Report Number
    2183996-2010-02533
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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) 2010, PT REPORTED HER BLOOD GLUCOSE HAS ELEVATED TO 493 MG/DL DUE TO THE INFUSION SET LEAKING UNDERNEATH THE ADHESIVE AT THE INFUSION SITE LOCATION. PT'S TARGET BLOOD GLUCOSE IS AROUND 100 MG/DL. PT STATED THIS WAS HER FIRST DAY USING THE NEW INFUSION SET AND HER FIRST TIME INSERTING THE NEW INFUSION SET. PT DOES NOT HAVE ANY SUPPLIES DURING THE CALL; UNABLE TO TROUBLESHOOT. PT REPORTED SHE WENT TO THE EMT DEPARTMENT AND PICKED UP SYRINGES TO CONDUCT MANUAL INJECTIONS; IS UNSURE OF THE AMOUNT SHE INJECTED TO CORRECT HER BLOOD GLUCOSE LEVELS. ADVISED PT TO CALL BACK FOR USER ASSISTANCE. ON CALL BACK ON (B)(6) 2010 FROM PT, ASSISTED PT WITH INSERTING THE NEW INFUSION SET. PT NO LONGER HAS INFUSION SET. 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 FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention INSULIN| INSULIN INFUSION SET