BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080272 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00852
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED ELEVATED BLOOD GLUCOSE, BRUISING AT HIS INFUSION SITES, AND MULTIPLE BENT INFUSION CANNULAS. PT CHANGES HIS INFUSION SITE IN THE EVENINGS AND EXPERIENCED ELEVATED BLOOD GLUCOSE OF 504-HI MG/DL THE FOLLOWING MORNINGS. INFUSION HEADSETS WERE INSERTED MANUALLY AND WITH THE INSERTION DEVICE. PT STARTED USING THIS TYPE OF INFUSION SET ON (B)(6) 2011, AND HE EXPERIENCED THESE COMPLAINTS AT LEAST 10 TIMES. TARGET BLOOD GLUCOSE IS 70-120 MG/DL. PT TREATED HYPERGLYCEMIA WITH INSULIN INJECTIONS. NO ERROR MESSAGES WERE RECEIVED ON THE INFUSION DEVICE. THERE WAS NO INSULIN LEAKAGE. INFUSION SETS WERE REPLACED AND REQUESTED 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 GWX075

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR INSULIN INFUSION DEVICE| INSULIN