BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS

    MDR report key: 2081555 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00983
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 5, 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
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS ASSOCIATED WITH THE ACCU-CHEK FLEXLINK PLUS RECALL INITIATED ON (B)(6) 2011. FURTHER INVESTIGATIONS ARE ONGOING WITHIN AN ASSIGNED TASKFORCE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE READINGS, AND BENT AND CRIMPED INFUSION SET CANNULAS. PT STATED THE ISSUE STARTED WITH THE NEW INFUSION SETS. PT REPORTED HE STARTED USING THE NEW INFUSION SETS TODAY AND ALREADY HAS HAD TO CHANGE THE INFUSION SET TWICE. PT STATED WITH THE FIRST INFUSION SITE HE NOTICED HIS BLOOD GLUCOSE READINGS WERE GOING UP RIGHT AFTER HE CHANGED THE SITE. PT REPORTED HIS READINGS WENT UP TO 265 MG/DL. PT STATED HE REMOVED THE INFUSION SITE AND NOTICED THE CANNULA WAS CRIMPED AND BENT, AND OUTSIDE OF HIS BODY. PT REPORTED HE CHANGED THE INFUSION SITE AND BOLUSED 12.0 UNITS OF INSULIN. PT STATED HIS READINGS STARTED TO GO DOWN A LITTLE AND THEN WENT BACK UP TO 250 MG/DL. PT REPORTED HE REMOVED THAT INFUSION SITE. PT STATED THE CANNULA APPEARED TO BE INSERTED CORRECTLY AND WASN'T BENT AT ALL AND THERE WERE NO VISIBLE LEAKS AT THE INFUSION SITE. PT REPORTED HE JUST CHANGED HIS INFUSION SITE ABOUT 40 MINS AGO AND HIS READINGS ARE HOLDING STEADY AROUND 272 MG/DL. PT'S TARGET BLOOD GLUCOSE RANGE IS 70-130 MG/DL. PT STATED HIS INFUSION DEVICE HAS NOT ALARMED WITH ANY BLOCKAGE ERRORS. PT IS USING A COMPETITOR'S INFUSION DEVICE. ADVISED PT TO MONITOR THE CURRENT SITE AND SEE IF READINGS COME DOWN. ON F/U CALL ON (B)(6) 2011, PT REPORTED HIS READINGS WERE DOING FINE UNTIL (B)(6) 2011 AROUND 4 PM. PT STATED FOR THE FIRST 22 HOURS OF USE HIS READINGS WERE FINE AND HAD COME DOWN TO HIS TARGET RANGE AND THEN WENT UP BEFORE DINNER. PT REPORTED HE BOLUSED FOR DINNER AND HIS READINGS CONTINUED TO INCREASE AFTER DINNER. PT STATED HIS READINGS CONTINUED TO BE ELEVATED EVEN AFTER HE GAVE SEVERAL CORRECTION BOLUSES. PT REPORTED HIS READING WAS 280 MG/DL AT 3 AM SO HE JUST WENT AHEAD AND CHANGED THE INFUSION SITE; JUST THE INFUSION HEADSET ONLY AND BOLUSED. PT STATED HIS READINGS HAVE COME BACK TO NORMAL SINCE THAT TIME. PT REPORTED THERE WAS NOT DAMAGE TO THE CANNULA. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE SUSPECT PRODUCT FOR EVAL.

    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 GWX075

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR INSULIN INFUSION PUMP| INSULIN