BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2143630 · Received June 3, 2011

    Report

    Report Number
    2183996-2011-01572
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    March 20, 2011
    Report Date
    May 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1491-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 THAT SHE EXPERIENCED ELEVATED BLOOD GLUCOSE IN THE 500 MG/DL RANGE DUE TO BENT INFUSION CANNULAS. NORMAL BLOOD GLUCOSE IS UNDER 200 MG/DL, AND PT BOLUSED TO DECREASE BLOOD GLUCOSE. THERE WERE NO CONCERNS WITH THE PREPARATION OF THE INFUSION SETS. PT DID HAVE CONCERNS WITH THE INSERTION PROCESS AND "JUST DID NOT LIKE THEM." THERE WAS NO INSULIN LEAKAGE. PT NOTICED THAT SEVERAL CANNULAS WERE BENT AFTER THE HEADSETS WERE REMOVED. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS, AND THE CONCERNS BEGAN A COUPLE OF MINUTES FOLLOWING INSERTION. PT STARTED USING THIS TYPE OF INFUSION SET AT THE (B)(6) 2011. NO PRODUCT WILL BE RETURNED FOR EVAL, AND PRODUCT WAS REPLACED. 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 FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX155

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR INSULIN INFUSION DEVICE| INSULIN