BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 2002120 · Received February 4, 2011

    Report

    Report Number
    2183996-2011-00122
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 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
    FL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, PT REPORTED HER LUER LOCK ON HER INFUSION SET IS CRACKING AND INSULIN IS LEAKING OUT OF HER INFUSION SET. PT STATED SHE IS WEARING THE INFUSION DEVICE IN A CASE. PT REPORTED SHE DISCOVERED THE LEAK BECAUSE SHE SMELLED AND FELT THE INSULIN THAT WAS LEAKING. PT STATED SHE HEARS THE CLICK WHEN SHE ATTACHES THE INFUSION HEADSET AND INFUSION TUBING. PT REPORTED SHE NOTICES THE ISSUE SOMETIMES AN HOUR OR TWO AFTER SHE PUTS THE NEW INFUSION TUBING IN. PT STATED THIS HAS HAPPENED WITH 2 SEPARATE BOXES AND SHE ONLY HAD 2 TUBINGS OUT OF THOSE BOXES THAT DID NOT CRACK. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED RETURN OF THE ALLEGED PRODUCT 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 9B124UF

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR INSULIN| INSULIN INFUSION SET