BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 1935346 · Received December 16, 2010

    Report

    Report Number
    2183996-2010-02651
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    December 11, 2010
    Report Date
    December 13, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED THE INFUSION HEADSET AND CONNECTOR WAS LEAKING INSULIN. THIS CAUSED HYPERGLYCEMIA IN THE RANGE OF MID-200 TO HIGH-300 MG/DL RANGE. NORMAL BLOOD GLUCOSE IS 100-160 MG/DL. NO ALERTS OR ERRORS WERE RECEIVED ON INFUSION DEVICE. INFUSION SET WAS CHANGED ON (B)(6) 2010 AND TWICE DURING TROUBLESHOOTING CALL. ADAPTER WAS A COUPLE OF WEEKS OLD. PATIENT DID NOT FORGET TO BOLUS, BUT HE DID NOT RECEIVE INTENDED AMOUNT DUE TO LEAK AT INFUSION HEADSET AND CONNECTOR. INSULIN WAS NOT EXPIRED. INFUSION DEVICE WAS NOT DROPPED OR CRACKED. DURING CALL, PATIENT NOTICED LEAK WHEN THE INFUSION SET WAS NOT PROPERLY CONNECTED. HE DID NOT HEAR A "CLICK" AND MAY HAVE HAD INFUSION CONNECTOR UPSIDE DOWN. PATIENT THEN INSERTED A NEW HEADSET AND THOUGHT IT WAS CONNECTED PROPERLY. HE ATTEMPTED TO BOLUS 14 UNITS AND WAS ABLE TO SEE INSULIN LEAK FROM THE INFUSION SET WITHIN 1 MINUTE. PATIENT DISCONNECTED AND REMOVED THE INFUSION TUBING AND REPORTED IT LOOKED "CHEWED UP," LIKE THE NEEDLE INSIDE THE CONNECTOR WAS BROKEN. PATIENT THEN REMOVED THE INFUSION HEADSET AND NOTICED THERE WAS NO CANNULA ATTACHED TO THE PLASTER. PATIENT INSPECTED THE INSERTION NEEDLE AND THE CANNULA WAS ATTACHED TO IT. PATIENT CHANGED INFUSION SET AGAIN, AND THIS SET FUNCTIONED AS INTENDED. PATIENT SUCCESSFULLY DELIVERED 2 BOLUSES OF 13 AND 14 UNITS. INFUSION SETS WERE REPLACED AND REQUESTED FOR EVALUATION. THE PATIENT 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 FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX042

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention INSULIN INFUSION DEVICE| INSULIN