BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACC-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1082392 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01118
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    FPA
    PMA / PMN Number
    K070189
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THAT THE CANNULA OF THE INFUSION SITE DOES NOT INSERT INTO HER SKIN ALONG WITH THE INTRODUCER NEEDLE. SHE STATED THAT WHEN THE INTRODUCER NEEDLE IS INSERTED, THE CANNULA "BUNCHES UP LIKE AN ACCORDION" AND INSERTION IS "REALLY PAINFUL". NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACC-CHEK ULTRAFLEX INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS, INC. NA 7K220UF

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR INSULIN| INSULIN INFUSION PUMP