BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2172373 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01746
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    March 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    ROCHE INSULIN DELIVERY SYSTEMS INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, 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, THE PT REPORTED EXPERIENCING ELEVATED BLOOD GLUCOSE OF 500-600 MG/DL. HER NORMAL BLOOD GLUCOSE RANGE IS 60-150 MG/DL. SHE TREATED ELEVATED BLOOD GLUCOSE BY INJECTING INSULIN VIA PEN. SHE NOTICED INSULIN WAS LEAKING FROM HER INFUSION SITE AND FOUND THE CANNULA WAS BENT. THERE IS NO SCAR TISSUE AT THE SITE. SHE STATED INSULIN WAS POOLING AND NOT BEING ABSORBED. SHE NORMALLY CHANGES THE HEADSET EVERY 3 DAYS, THE INFUSION TUBING EVERY 6 DAYS, AND THE INSULIN CARTRIDGE EVERY WEEK AND A HALF. SHE WAS ADVISED TO CHANGE THE CARTRIDGE EVERY 6 DAYS. SHE STATED, SHE HAS BEEN CHANGING THE INFUSION SETS MORE OFTEN DUE TO ELEVATED BLOOD GLUCOSE. THE PT DID NOT REQUIRE TREATMENT FROM A HEALTH CARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE ALLEGED INFUSION SET WAS DISCARDED. NO PRODUCT WILL BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 9L192UF

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR INSULIN INFUSION PUMP| INSULIN