BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2002113 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00132
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD AND RESULTS: NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, HUSBAND REPORTED INSULIN HAS LEAKED UNDERNEATH THE INFUSION SET ADHESIVE DURING THE PREVIOUS MONTH. PT CHANGED THE HEADSET IMMEDIATELY TO AVOID ANY BLOOD GLUCOSE CONCERNS AND NOTICED THE CANNULAS WERE KINKED. PT ROTATES INFUSION SITES AROUND ABDOMEN AND TRIES TO AVOID SCAR TISSUE. HUSBAND WAS EDUCATED ON PROPER TECHNIQUE FOR INSERTION, AND PT WAS SENT INSERTION DEVICE AND COMPLIMENTARY INFUSION SETS. NO PRODUCT WAS REQUESTED FOR EVAL. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. 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 GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INSULIN| INSULIN INFUSION DEVICE