BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1821824 · Received August 26, 2010

    Report

    Report Number
    2183996-2010-01720
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 10, 2010
    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
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, PATIENT REPORTED SHE "SMELLED INSULIN REALLY STRONG" EARLIER IN THE DAY. PATIENT CHANGES INFUSION HEADSET EVERY 2 DAYS AND INFUSION TUBING EVERY 5 DAYS. PATIENT DOES NOT REUSE INSULIN CARTRIDGES AND ADAPTER IS BEING USED WITHIN SPECIFICATION. PATIENT USES THE CORRECT TYPE OF BATTERY IN THE INFUSION DEVICE. PATIENT COULD NOT FIND LEAKING ANYWHERE WITHIN THE SYSTEM, INCLUDING INSIDE OF THE INFUSION DEVICE. PATIENT REPORTED, IT SMELLED LIKE IT WAS LEAKING THROUGH THE INFUSION TUBING. INFUSION SET WAS REQUESTED FOR EVALUATION. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PATIENT DID NOT REQUIRE TREATMENT 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 INFUSION SET INSULIN INFUSION SET FPA ROCHE INSULIN DELIVERY SYSTEMS INC. NA 9K120UF

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR INSULIN| INFUSION DEVICE