BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2080241 · Received April 6, 2011

    Report

    Report Number
    2183996-2011-00864
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1486-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 DUE TO BENT INFUSION CANNULAS. THIS HAS OCCURRED INTERMITTENTLY SINCE PT STARTED A NEW TYPE OF INFUSION SET 2 MONTHS AGO. ON (B)(6) 2011, PT WENT TO BED AND HIS BLOOD GLUCOSE WAS IN THE 300'S MG/DL. HE DELIVERED A BOLUS AND WOKE UP AT 3 AM. HIS BLOOD GLUCOSE WAS STILL ELEVATED SO HE BOLUSED 5 UNITS. HE WOKE AT 4:30 AM AND FELT NAUSEOUS AND THREW UP. BLOOD GLUCOSE WAS 414 MG/DL. PT REMOVED THE INFUSION HEADSET AND THE CANNULA WAS BENT. NORMAL BLOOD GLUCOSE IS 80-160 MG/DL. AN E4 OCCLUSION ERROR WAS RECEIVED ON THE MORNING OF THE REPORT. PT RECENTLY HAD OPEN HEART SURGERY AND HAS HAD INCREASED STRESS. THERE WERE NO ISSUES WITH THE PREPARATION, INSERTION, OR REMOVAL OF THE INFUSION SET. INSULIN DID LEAK FROM THE INFUSION CANNULAS. HEADSETS WERE INSERTED MANUALLY. NO PRODUCT WILL BE RETURNED FOR EVAL. PRODUCT WAS REPLACED. 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 GWX133

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR INSULIN INFUSION DEVICE| INSULIN