BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1032251 · Received April 18, 2008

    Report

    Report Number
    2183996-2008-00555
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    April 2, 2008
    Report Date
    April 2, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS, INC.
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    THE PT REPORTED HE HAS NOTICED MOISTURE IN THE CARTRIDGE COMPARTMENT OF HIS INSULIN INFUSION DEVICE. HE STATED AT FIRST HE SAW "A LITTLE BIT OF HAZE" AND NOW HE SEES "LITTLE DROPLETS FORMING" INSIDE THE COMPARTMENT. THE PT STATED HE IS USING CARTRIDGES THAT EXPIRED ON 2006-12. THE PT WAS ADVISED NOT TO USED EXPIRED PRODUCT. THE PT STATED HE WILL SWITCH TO HIS OLD INFUSION DEVICE. THE PT WAS ADVISED TO DRY OUT THE CARTRIDGE COMPARTMENT WITH A COTTON SWAB. REPEATED ATTEMPTS TO FOLLOW UP WITH THE PT WERE UNSUCCESSFUL. THE PT DID NOT REPORT BLOOD GLUCOSE CONCERNS RELATED TO THIS ISSUE. THE PT DID NOT REQUIRE ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PRODUCT WAS REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET