BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1082388 · Received July 25, 2008

    Report

    Report Number
    2183996-2008-01112
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 19, 2008
    Report Date
    July 10, 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
    SC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON 07/10/08 THE PATIENT REPORTED THAT A FEW WEEKS AGO THE CANNULA OF HIS INSULIN INFUSION SET WAS KINKED. HE SAID HE DISCOVERED THIS WHEN HE RECEIVED AN OCCLUSION MESSAGE ON HIS INSULIN INFUSION DEVICE. HE STATED HE CHANGED AND DISCARDED HIS INFUSION SET AND HAS HAD NO FURTHER ISSUES. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN INFUSION PUMP| INSULIN