BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 2172424 · Received June 17, 2011

    Report

    Report Number
    2183996-2011-01816
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 31, 2011
    Report Date
    May 31, 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
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HE SMELLED INSULIN SO HE CHECKED HIS INFUSION SITE AND IT WAS LEAKING. PT STATED UPON REMOVING THE INFUSION SITE, HE NOTICED THE INFUSION SET CANNULA WAS BENT. PT REPORTED HE INSERTED THE INFUSION SITE ON (B)(6) 2011. PT STATED HIS BLOOD GLUCOSE WAS RATHER HIGH THIS MORNING WITH A READING OF 280 MG/DL. PT'S NORMAL BLOOD GLUCOSE RANGE IS 70-90 MG/DL. PT REPORTED HE NOTICED WHEN HE ATTEMPTED TO BOLUS THAT THE INSULIN WAS POOLING AT THE INFUSION SITE AND IT JUST DIDN'T FEEL RIGHT TO HIM. PT STATED THAT IS WHEN HE DISCOVERED THE LEAK FROM SMELLING INSULIN. PT REPORTED HE DID HEAR AN AUDIBLE CLICK WHEN HE CONNECTED THE INFUSION HEADSET TO THE INFUSION TUBING. PT STATED HE USES THE INSERTION ASSIST DEVICE TO INSERT THE INFUSION SITES. PT REPORTED NO ERROR MESSAGE DISPLAYED ON THE INFUSION DEVICE OTHER THAN A LOW BATTERY ERROR MESSAGE TODAY. PT STATED HE CHANGED THE BATTERY AND THE ERROR MESSAGE WENT AWAY. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. REQUESTED RETURN OF THE ALLEGED INFUSION SET FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 0H071UF

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR INSULIN| INSULIN INFUSION PUMP