BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK FLEXLINK PLUS INFUSION SET

    MDR report key: 2030666 · Received March 22, 2011

    Report

    Report Number
    2183996-2011-00582
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    December 2, 2010
    Report Date
    March 2, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FRN
    PMA / PMN Number
    K100704
    Removal / Correction Number
    Z-1490-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 WHEN SHE FIRST INSERTS THE INFUSION SITE, THE INFUSION SET CANNULA IS NOT STRAIGHT. PT STATED THE CANNULA HAS A SLIGHT CURVE TO IT AND DOESN¿T APPEAR TO BE STRAIGHT LIKE SHE THINKS IT SHOULD BE. PT REPORTED SHE HAS HAD AN ELEVATED BLOOD GLUCOSE FOR THE PAST 3 MONTHS SINCE SWITCHING TO THE INFUSION SETS. PT STATED WHEN SHE REMOVES HER INFUSION SITE, THE CANNULA IS BENT. PT STATED THERE IS ONLY ONE KINK IN THE CANNULA AND IT APPEARS TO BE AT A 90 DEGREE ANGLE. PT REPORTED SEEING BLOOD AT THE INFUSION SITE AS WELL. PT¿S NORMAL BLOOD GLUCOSE RANGE IS 80¿120 MG/DL. PT STATED SHE IS EXPERIENCING BLOOD GLUCOSE READINGS IN THE 200-300 MG/DL RANGE. PT REPORTED SHE NOTICES THE INCREASE A COUPLE OF HRS AFTER INSERTING THE INFUSION SITE BUT IT CAN BE MORE THAN THAT SOMETIMES. PT USES THE INSERTION ASSIST PLUS DEVICE TO INSERT THE INFUSION SETS. PT STATED WHEN SHE INSERTS THE INFUSION HEADSET, IT WILL POP BACK OUT. PT REPORTED THE HEADSET IS INSERTED ALL THE WAY WHEN IT POPS BACK OUT. ADVISED PT ON ADDITIONAL TYPES OF INFUSION SETS AVAILABLE. PT NO LONGER HAS THE ALLEGED INFUSION SETS. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT RETURN WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK FLEXLINK PLUS INFUSION SET INSULIN INFUSION SET FRN ROCHE INSULIN DELIVERY SYSTEMS INC. NA GWX113

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INSULIN| INSULIN INFUSION PUMP