BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1001318 · Received February 19, 2008

    Report

    Report Number
    2183996-2008-00142
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    February 2, 2008
    Report Date
    February 2, 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

    Additional Manufacturer Narrative · 1

    NO PROD WILL BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    ON 02/02/2008, THE PT REPORTED THAT WHILE CHANGING THE INSULIN CARTRIDGE THE PLUNGER BECAME STUCK TO THE PISTON ROD OF THE INFUSION DEVICE AND A SMALL AMOUNT OF INSULIN SPILLED INTO THE CARTRIDGE COMPARTMENT. SHE STATED SHE DRIED THE INSULIN FROM THE INFUSION DEVICE. SHE WAS INSTRUCTED HOW TO REMOVE THE PLUNGER FROM THE PISTON ROD. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. NO PROD WILL 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 INFUSION SET| INSULIN