BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHECK FLEXLINK PLUS

    MDR report key: 2110277 · Received May 20, 2011

    Report

    Report Number
    2183996-2011-01456
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    January 30, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1489-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL. THIS COMPLAINT IS ASSOCIATED WITH THE ACCU-CHEK FLEXLINK PLUS RECALL INITIATED ON (B)(4) 2011. FURTHER INVESTIGATIONS ARE ONGOING WITHIN AN ASSIGNED TASK-FORCE.

    Description of Event or Problem · 1

    THE PT REPORTED HE HAS BEEN EXPERIENCING ELEVATED BLOOD GLUCOSE READINGS UP TO 520 MG/DL WITH THE INFUSION SETS. PT STATED THE INFUSION CANNULA GOES INTO HIS BODY BUT THEN IT COMES OUT DURING USE. PT'S TARGET BLOOD GLUCOSE IS 180-220 MG/DL. PT STATED HE IS TREATING HIS ELEVATED READINGS WITH AN INSULIN PEN. PT REPORTED HE HAS ONLY USED THE INFUSION SETS FOR ONE WEEK AND HAS HAD TO CHANGE THE INFUSION SITE UP TO 3 TIMES PER DAY BECAUSE THE INSULIN KEEPS LEAKING DOWN HIS LEG AS THE CANNULA COMES OUT OF HIS BODY. PT STATED HE WANTED A DIFFERENT TYPE OF INFUSION SET. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PROD FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHECK FLEXLINK PLUS INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS, INC. NA GWX112

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR INSULIN| INSULIN INFUSION PUMP