BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1942503 · Received December 22, 2010

    Report

    Report Number
    2183996-2010-02685
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 9, 2010
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K100704
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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) 2010, COMPANY REPRESENTATIVE REPORTED PT WAS HOSPITALIZED WITH BLOOD GLUCOSE ABOVE 600 MG/DL AND DIABETIC KETOACIDOSIS. PT HAS HAD ONGOING CONCERNS WITH INFUSION HEADSETS DUE TO CANNULAS BECOMING KINKED UPON INSERTION. CLINICAL SPECIALIST SCHEDULED APPOINTMENT TO EDUCATE ON USAGE OF INSERTION DEVICE. PT THEN CALLED TO PROVIDE ADDITIONAL DETAILS. HE WOKE UP ON THE MORNING OF (B)(6) 2010, AND BLOOD GLUCOSE WAS 312 MG/DL. PT BOLUSED AND RECEIVED AN E4 OCCLUSION ERROR. INSULIN LEAKED OUT OF THE INFUSION CANNULA AND RAN DOWN HIS LEG. WHEN THE CANNULA WAS REMOVED, IT WAS BENT TO 90 DEGREES. HE WENT TO DOCTOR'S OFFICE, BLOOD GLUCOSE WAS IN THE 500 MG/DL RANGE, AND HE WAS THEN SENT TO THE EMERGENCY ROOM. PT WAS TREATED WITH INSULIN INJECTIONS AND FLUIDS AND REMAINED CONNECTED TO HIS INFUSION DEVICE. HE WAS ADMITTED TO THE INTENSIVE CARE UNIT FOR 12 HOURS, AND BLOOD GLUCOSE WAS 136 MG/DL WHEN HE WAS RELEASED. BLOOD GLUCOSE ELEVATED TO 212 MG/DL WITHIN AN HOUR OF LEAVING HOSPITAL. PT STARTED TO USE THE INSERTION DEVICE AND REPORTED THE CANNULAS HAVE NOT BEEN BENT SINCE THEN. NORMAL BLOOD GLUCOSE IS "IN THE 200'S" MG/DL. INFUSION SETS, ADAPTER, BATTERY COVER, AND INSULIN CARTRIDGES ARE USED PER SPECIFICATION. INSULIN REACHES ROOM TEMPERATURE BEFORE THE CARTRIDGE IS FILLED. THERE WAS NO BLOOD IN THE INFUSION TUBING OR CONCERNS WITH AIR BUBBLES. THE TUBING HAD NOT BECOME DISCONNECTED. TIME, DATE, AND BASAL RATES WERE PROGRAMMED CORRECTLY. THERE WERE NO CHANGES TO DIET, MEDICATION, OR LIFESTYLE. INFUSION DEVICE WAS NOT DROPPED, DAMAGED, OR EXPOSED TO MOISTURE OR HUMIDITY. PT WAS SENT INFUSION SET WITH LONGER CANNULA TO TRY. FOLLOW-UP WAS PROVIDED BY THE PT ON (B)(6) 2010. HE REPORTED FEELING MUCH BETTER AND THAT BLOOD GLUCOSE RETURNED TO NORMAL. ONCE HE STARTED USING THE INSERTION DEVICE, HE DID NOT HAVE FURTHER CONCERNS WITH THE INFUSION SETS. PT REPORTED HE WAS NOT DIAGNOSED WITH DIABETIC KETOACIDOSIS AT THE HOSPITAL, ONLY HIGH BLOOD GLUCOSE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX042

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R