BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080223 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00843
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    March 8, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1492-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 400 MG/DL RANGE DUE TO A BENT INFUSION CANNULA. PT VOMITED DUE TO THIS. NORMAL BLOOD GLUCOSE IS 130-170 MG/DL. PT WAS ABLE TO TREAT HYPERGLYCEMIA HERSELF AFTER SHE CHANGED THE INFUSION SET. THIS OCCURRED IN (B)(6) 2010. INFUSION HEADSET WAS INSERTED USING THE INSERTION DEVICE. PRODUCT WAS REPLACED. ALLEGED INFUSION SET WAS 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR INSULIN INFUSION DEVICE| INSULIN