BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX

    MDR report key: 2081509 · Received April 12, 2011

    Report

    Report Number
    2183996-2011-00950
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    March 13, 2011
    Report Date
    March 13, 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
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HYPERGLYCEMIA AND INSULIN LEAKAGE FROM THE INFUSION SET. PT BELIEVES THE LEAK ORIGINATED AT THE CONNECTOR OF THE TUBING, AND SHE DISCOVERED THE LEAK WHEN CHANGING HER INFUSION SITE. PT DID HEAR AN AUDIBLE CLICK WHEN SHE CONNECTED THE TUBING TO THE HEADSET. INFUSION HEADSET IS INSERTED AT A 90 DEGREES ANGLE USING THE INSERTION DEVICE. BLOOD GLUCOSE ELEVATED AS HIGH AS 342 MG/DL, AND NORMAL BLOOD GLUCOSE IS 120 MG/DL. PT BOLUSED TO TREAT HYPERGLYCEMIA. INFUSION SET AND INSULIN CARTRIDGE HAD BEEN IN USE FOR 2 DAYS. PT ADVISED SHE WOULD CHANGE HER INFUSION SET. INFUSION SET WAS REQUESTED FOR EVAL. F/U WAS COMPLETED, AND PT REPORTED HER BLOOD GLUCOSE RETURNED TO NORMAL. THE PT DID NOT REQUIRE ASSISTANCE 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 ULTRAFLEX INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 0H071UF

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR INSULIN| INSULIN INFUSION DEVICE