BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ULTRAFLEX INFUSION SET

    MDR report key: 1030790 · Received April 17, 2008

    Report

    Report Number
    2183996-2008-00487
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    October 27, 2008
    Report Date
    March 27, 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
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT OVER THE PAST 4-5 MONTHS "ABOUT" 6 INFUSION SETS HAVE FALLEN OFF OF HIS BODY. HE STATED THAT ON EACH OCCURRENCE THE HEADSET WAS IN PLACE FOR LESS THAN 1 DAY. HE STATED THAT HE NOTICES THE HAIR ON HIS BODY PREVENTS THE ADHESIVE FROM STICKING TO HIS SKIN. HE WAS SENT SAMPLES OF ADHESIVES. UPON FOLLOW UP ABOUT ONE WEEK LATER, THE PT STATED THAT HE HAD JUST BEGUN TO USE THE ADHESIVE AND NO FURTHER ISSUES. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WILL BE RETURNED FOR EVAL.

    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