BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1033519 · Received April 23, 2008

    Report

    Report Number
    2183996-2008-00570
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 10, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    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

    THE PT REPORTED THE ADHESIVE ON HIS INSULIN INFUSION SETS ARE NOT PROPERLY ADHERING. HE STATED THE SETS LAST FOR ABOUT 1 DAY BEFORE THEY START TO PEEL OFF. HE SAID HE IS USING AN EXTRA ADHESIVE AND DOES NOT USE LOTION ON HIS SKIN. HE STATED, HE DOES NOT HAVE THE LOT NUMBERS OR EXPIRATION DATES FOR THE INFUSION SETS AT ISSUE. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. THE PRODUCT WAS REPLACED AND REQUESTED TO 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 NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION PUMP