BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK RAPID D INFUSION SET

    MDR report key: 1193215 · Received October 7, 2008

    Report

    Report Number
    2183996-2008-01526
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    September 18, 2008
    Report Date
    September 18, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K003977
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT REPORTED THE ADHESIVE ON HIS INSULIN INFUSION SETS HAVE NOT ADHERED PROPERLY FOR THE PAST MONTH. HE STATED THE ADHESIVE STICKS TO HIS HAIR, BUT DOES NOT STICK AS WELL TO HIS SKIN. HE SAID HE USES ALCOHOL TO CLEAN THE AREA AND ALLOWS IT TO DRY COMPLETELY BEFORE INSERTING THE HEADSET. HE STATED HE HAS NOT KEPT ANY OF THE HEADSETS THAT HAVE PEELED OFF. IT WAS RECOMMENDED THE PATIENT USE TEGADERM AND AN INFUSION SET WITH A LONGER CANNULA. THE SANDWICH TECHNIQUE WAS EXPLAINED TO THE PATIENT. ON FOLLOW UP WITH THE PATIENT, HE STATED THE LONGER CANNULA INFUSION SETS HAVE WORKED SO WELL HE HAS NOT HAD TO USE THE TEGADERM. THE PATIENT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PATIENT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PART TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK RAPID D INFUSION SET INSULIN INFUSION SET FPA DISETRONIC MEDICAL SYSTEMS NA 313357

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR INSULIN| INSULIN INFUSION PUMP