BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081683 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-01002
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 11, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES. INFORMATION CONTAINED WITHIN THIS REPORT IS ALL THAT IS AVAILABLE AT THIS TIME. IF FURTHER INFORMATION IS OBTAINED, IT WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    PATIENT REPORTED ELEVATED BLOOD GLUCOSE OF APPROXIMATELY 450 MG/DL DUE TO A BENT INFUSION CANNULA. PATIENT CHANGED THE INFUSION SET IN THE MORNING AND BLOOD GLUCOSE ELEVATED ABOVE HER NORMAL RANGE OF 280-300 MG/DL. PATIENT SAW HER DIABETOLOGIST WHO SUGGESTED SHE CHANGE THE INFUSION SET. WHEN THE HEADSET WAS REMOVED, SHE NOTICED THE CANNULA WAS BENT. "EVERYTHING WENT BETTER" AFTER THE INFUSION SET WAS CHANGED. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. INFUSION SET WAS REQUESTED FOR EVALUATION. ADDITIONAL DETAILS WERE NOT PROVIDED.

    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 GWX175

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION DEVICE