BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC *T DIFF 2 ANALYZER

    MDR report key: 3235445 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01510
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K990352
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2013. THE FSE INSPECTED THE INSTRUMENT DID NOT FIND ANY LEAKS INSIDE THE INSTRUMENT. THE FSE ATTEMPTED TO RECREATE THE ISSUE BY RUNNING THE INSTRUMENT BUT DID NOT FIND ANY LEAKS. THE FSE FOUND THAT THE HEMOGLOBIN (HGB) LAMP AND PHOTODIODE WERE NOT WORKING. THE FSE REPLACED THE HGB LAMP AND THE PHOTODIODE AND THE INSTRUMENT RAN AND PASSED ALL BACKGROUNDS. FAILURE MODE: THE FSE WAS UNABLE TO REPRODUCE THE LEAK. THE CAUSE OF THE FAILING HGB BACKGROUNDS WAS THAT THE HGB LAMP AND PHOTODIODE WERE NOT WORKING. THE INSTRUMENT OPERATED AS INTENDED BY FAILING THE HGB BACKGROUNDS DURING THE STARTUP, ALERTING THE OPERATOR TO AN INSTRUMENT PROBLEM. BECKMAN COULTER INTERNAL NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) A LEAK INSIDE THE COULTER AC *T DIFF 2 ANALYZER. THE CUSTOMER ALSO REPORTED THAT THE INSTRUMENT WAS FAILING HEMOGLOBIN (HGB) BACKGROUNDS DURING A STARTUP WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 10 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THE LABORATORY¿S EXPOSURE CONTROL/RISK MANAGEMENT PLANS ARE IN PLACE. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES AT THE TIME OF THE OCCURRENCE. NO ONE CAME IN CONTACT WITH THE FLUID. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED AS A RESULT OF THIS EVENT. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334905 COULTER® AC *T DIFF 2 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER ACT DIFF 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1