BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK TENDER INFUSION SET

    MDR report key: 1163444 · Received September 10, 2008

    Report

    Report Number
    2183996-2008-01384
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 20, 2008
    Report Date
    August 20, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K972135
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED HER NEW INSULIN INFUSION HEADSETS ARE NOT PROPERLY ADHERING. SHE STATED SHE IS ON HER THIRD HEADSET FOR THE DAY. SHE STATED THE BACK AREA OF THE HEADSET ADHERES, BUT THE FRONT PORTION DOES NOT. SHE SAID SHE WILL SECURE THE HEADSET THE MEDICAL TAPE. THE PATIENT WAS SENT A COMPLIMENTARY GUIDE TO INFUSION SITE MANAGEMENT, A BOX OF INFUSION SETS, AND SOME EXTRA ADHESIVE. THE PT 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. PRODUCT WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK TENDER INFUSION SET INSULIN INFUSION SET FOZ DISETRONIC MEDICAL SYSTEMS NA 601294

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR INSULIN INFUSION PUMP| INSULIN