BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1033522 · Received April 23, 2008

    Report

    Report Number
    2183996-2008-00575
    Event Type
    Malfunction
    Date Received
    April 23, 2008
    Date of Event
    April 13, 2008
    Report Date
    April 13, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    FPA
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED THAT AS SHE WAS REMOVING THE INSULIN CARTRIDGE FROM HER INFUSION DEVICE THIS MORNING, SHE NOTICED A LITTLE DRIP OF INSULIN COMING OUT OF THE CARTRIDGE. SHE STATED SHE DRIED OUT THE COMPARTMENT WITH A COTTON SWAB BUT THEN COULD NOT PLACE THE CARTRIDGE BACK INTO HER INFUSION DEVICE. SHE SAID THE CARTRIDGE WILL NOT GO IN OVER THE PISTON ROD ALTHOUGH THE PISTON ROD DOES NOT APPEAR TO BE TILTED. SHE STATED SHE MAY HAVE "APPLIED TOO MUCH PRESSURE TO THE PISTON ROD WHEN I WAS CLEANING IT WITH A COTTON SWAB." THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS 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 SPIRIT INSULIN INFUSION PUMP FPA DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET