BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK

    MDR report key: 2170881 · Received June 22, 2011

    Report

    Report Number
    2183996-2011-01873
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 7, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFO CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFO IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PT REPORTED, THE INFUSION SETS ARE LEAKING INSULIN AFTER 24 HOURS OF USE. THIS OCCURRED WITH THE LAST 3 INFUSION SETS WHICH WERE ALL FROM THE SAME LOT AND ON A FEW SEPARATE OCCASIONS. PT REPORTED, THE INFUSION SET SELF-ADHESIVE BECOMES WET DURING BOLUSES, AND HE IS CONFIDENT THE LEAK IS FROM THE CANNULA AND NOT FROM THE CONNECTION OF THE INFUSION TUBING AND HEADSET. NO PHYSIOLOGICAL EFFECTS WERE EXPERIENCED. INFUSION SETS WERE REQUESTED FOR EVAL, AND PT WAS ADVISED TO CALL WITH ADD'L CONCERNS. PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO ADD'L DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA 7490205

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION DEVICE