BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080256 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00874
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    March 10, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1491-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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, FATHER REPORTED THAT PT HAS EXPERIENCED ELEVATED BLOOD GLUCOSE DUE TO CRIMPED INFUSION CANNULAS. BLOOD GLUCOSE HAS ELEVATED TO THE 300-400S MG/DL, AND NORMAL BLOOD GLUCOSE IS 110 MG/DL. PT USED INJECTION THERAPY TO TREAT HYPERGLYCEMIA. FATHER HELPED THE PT INJECT THE INSULIN, BUT THIS IS A NORMAL PRACTICE. THERE WERE NO CONCERNS WITH THE INSERTION OF THE INFUSION SET. INFUSION SITES WERE LOCATED ON ABDOMEN BELOW PT'S WAIST. THERE WAS NO INSULIN LEAKAGE. INFUSION SITES ARE TYPICALLY CHANGED AT 10 PM, AND PT WOULD WAKE UP AT 3-4 AM WITH HIGH BLOOD GLUCOSE. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. THIS FIRST OCCURRED IN (B)(6) 2010, AND HAPPENED 10-15 TIMES. ALLEGED INFUSION SETS WERE DISCARDED AND WILL NOT BE RETURNED 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 GWX155

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR INSULIN INFUSION DEVICE| INSULIN