BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080270 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00848
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 17, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ELEVATED BLOOD GLUCOSE IN THE RANGE OF 200-300 MG/DL DUE TO BENT INFUSION CANNULAS. NORMAL BLOOD GLUCOSE IS 130-165 MG/DL. PT TREATED HYPERGLYCEMIA BY CHANGING THE INFUSION SET. INFUSION HEADSETS WERE INSERTED MANUALLY. PT USED THE INFUSION SET FOR 1-2 DAYS BEFORE HER BLOOD GLUCOSE ELEVATED. AT THAT POINT, SHE WOULD REMOVE THE HEADSET AND NOTICE THE CANNULA WAS BENT. PT STARTED USING THIS TYPE OF INFUSION SET IN (B)(6) 2011, AND EXPERIENCED THIS CONCERN WITH EACH INFUSION SET FROM THAT BOX. PRODUCT WAS REPLACED. ALLEGED INFUSION SETS WERE NOT AVAILABLE TO RETURN FOR EVAL. 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 GWX150

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR INSULIN| INSULIN INFUSION DEVICE