BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1001347 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00147
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 1, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 02/01/2008, THE PT REPORTED THAT THE PISTON ROD OF HIS INFUSION DEVICE WAS "MULTI-COLORED AND DOES NOT LOOK CLEAN." HE STATED IT LOOKED "OXIDIZED." HE STATED THAT INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT WHILE CHANGING THE INSULIN CARTRIDGE AND HE DID NOT CLEAN OUT THE CARTRIDGE COMPARTMENT. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PRODUCT WAS REPLACED AND 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 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET