BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2091056 · Received May 11, 2011

    Report

    Report Number
    2183996-2011-01386
    Event Type
    Malfunction
    Date Received
    May 11, 2011
    Date of Event
    December 25, 2010
    Report Date
    April 12, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. THIS COMPLAINT IS ASSOCIATED WITH THE ACCU-CHEK FLEXLINK PLUS RECALL INITIATED ON 02/21/2011. FURTHER INVESTIGATIONS ARE ONGOING WITHIN AN ASSIGNED TASKFORCE.

    Description of Event or Problem · 1

    THE PATIENT REPORTED, SHE INSERTED A NEW INFUSION SET HEADSET AT 7:00 AM ON (B)(6) 2010 - (B)(6) 2010 AND AT 9:00 AM THE NEXT MORNING, SHE NOTED IRRITATION ON HER SKIN. SHE REMOVED THE HEADSET AND FOUND THE CANNULA WAS BENT AND THERE WAS BLEEDING AT THE SITE. NO BLOOD GLUCOSE ISSUES WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE INFUSION SET WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    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 GWX138

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR INSULIN| INSULIN INFUSION PUMP