BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081698 · Received April 13, 2011

    Report

    Report Number
    2183996-2011-01012
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    August 1, 2010
    Report Date
    March 15, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS, INC.
    Product Code
    FRN
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1487-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS ASSOCIATED WITH THE ACCU-CHEK FLEXLINK PLUS RECALL INITIATED ON 02/21/2011. FURTHER INVESTIGATIONS ARE ONGOING WITHIN AN ASSIGNED TASKFORCE. THIS INCIDENT OCCURRED OUTSIDE OF THE UNITED STATES.

    Description of Event or Problem · 1

    PATIENT REPORTED ELEVATED BLOOD GLUCOSE DUE TO BENT INFUSION CANNULAS. THERE WERE NO ISSUES DURING THE PREPARATION OF THE INFUSION SET. THE INFUSION CANNULA DID NOT INSERT PROPERLY AND WAS JUST SITTING UNDER PATIENT'S SKIN. THIS WAS DISCOVERED 1 HOUR AFTER INSERTION WHEN PATIENT TESTED HER BLOOD GLUCOSE. SHE REMOVED THE HEADSET AND NOTICED THE CANNULA WAS BENT OR KINKED. THERE WAS NO INSULIN LEAKAGE. INSERTION DEVICE WAS USED TO INSERT THE HEADSETS. PATIENT STARTED USING THIS TYPE OF INFUSION SET IN (B)(6), 2010, AND THESE CONCERNS HAVE BEEN ONGOING SINCE THEN. PATIENT PROVIDED AN EXAMPLE OF ELEVATED BLOOD GLUCOSE. ON (B)(6) 2011 AT 8:00 AM, THE INFUSION HEADSET WAS CHANGED. BLOOD GLUCOSE WAS 7.3 MMOL/L (131.4 MG/DL) AT THAT TIME. BLOOD GLUCOSE WAS 19 MMOL/L (342 MG/DL) AT 10:30 AM AND 21.4 MMOL/L (385.2 MG/DL) AT 11:30 AM. PATIENT CHANGED THE INFUSION HEADSET AGAIN AND NOTICED THE CANNULA WAS BENT. ALLEGED PRODUCT WAS REQUESTED FOR EVALUATION. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. ADDITIONAL DETAILS WERE NOT PROVIDED.

    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 GWX070

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION DEVICE