BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2070399 · Received April 18, 2011

    Report

    Report Number
    2183996-2011-01084
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 5, 2011
    Report Date
    March 19, 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
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT'S MOTHER REPORTED, THE PATIENT EXPERIENCED ELEVATED BLOOD GLUCOSE OF 350-370 MG/DL WHILE USING THE INFUSION SETS. HIS NORMAL BLOOD GLUCOSE RANGE IS 180 MG/DL. HE WOULD BOLUS INSULIN TO LOWER HIS BLOOD GLUCOSE AND HIS READINGS WOULD INCREASE. HE CHANGED THE INFUSION SET AND FOUND THE SITE WAS LEAKING. THE INFUSION SITE HAD BEEN IN PLACE FOR A FEW HOURS PRIOR TO NOTICING THE LEAK. THE PATIENT'S BLOOD GLUCOSE DECREASED AFTER THE INFUSION SITE WAS CHANGED. THE PATIENT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED INFUSION SET WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 GWX190

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR INSULIN| INSULIN INFUSION PUMP