BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACS:180 SE

    MDR report key: 625736 · Received August 10, 2005

    Report

    Report Number
    2432235-2005-00011
    Event Type
    Other
    Date Received
    August 10, 2005
    Date of Event
    July 13, 2005
    Report Date
    July 14, 2005
    Manufacturer
    KMC SYSTEMS INC,
    Product Code
    LCI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN JULY 2005 A HEALTHCARE PROFESSIONAL AT A MEDICAL CENTER REPORTED THAT ON THE PREVIOUS DAY AN OPERATOR OF AN ACS:180 ANALYZER SCRAPED THEIR HAND WITH THE INSTRUMENTS SAMPLE PROBE. THE OPERATOR WASHED THE SITE OF THE INJURY, APPLIED A DISINFECTANT AND BANDAGED IT. THE OPERATOR RECEIVED THE SCRATCH WHILE TRYING TO REPLACE THE SAMPLE PROBE ON THE INSTRUMENT DUE TO A CLOG IN THE PROBE, ALL INDICATIONS ARE THAT THE OPERATOR FOLLOWED INSTRUCTIONS AND WAS USING PROPER PROTECTIVE EQUIPMENT AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS:180 SE IMMUNOASSAY SYSTEM LCI KMC SYSTEMS INC, ACS:180 *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other