BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2063334 · Received April 11, 2011

    Report

    Report Number
    2183996-2011-00948
    Event Type
    Malfunction
    Date Received
    April 11, 2011
    Date of Event
    February 26, 2011
    Report Date
    March 12, 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
    WI, 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, PATIENT REPORTED ELEVATED BLOOD GLUCOSE OF 197 MG/DL DUE TO A BENT INFUSION CANNULA. THERE WAS NO INSULIN LEAKAGE. PATIENT HAD DIFFICULTY PRESSING THE BLUE BUTTON, BUT THERE WERE NO ISSUES WITH INSERTION OF THE INFUSION SET. PATIENT BOLUSED TO DECREASE BLOOD GLUCOSE AND THEN USED INJECTION THERAPY WHEN THAT DID NOT WORK. NORMAL BLOOD GLUCOSE IS 130-140 MG/DL. PATIENT FOUND THE INFUSION CANNULA WAS BENT IN HALF AFTER THE HEADSET WAS REMOVED. INSERTION DEVICE WAS USED TO INSERT THE HEADSET, AND BLOOD GLUCOSE ELEVATED THE SAME DAY. PATIENT ONLY EXPERIENCED THIS CONCERN ONCE. PRODUCT WAS REPLACED. FOLLOW-UP WAS COMPLETED ON (B)(6) 2011, AND PATIENT REPORTED HIS BLOOD GLUCOSE WAS WITHIN NORMAL RANGE. NO PRODUCT WAS REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE ASSISTANCE 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 GWX190

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR INSULIN| INSULIN INFUSION DEVICE