BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER AC*T 8/10 ANALYZER

    MDR report key: 2960016 · Received February 13, 2013

    Report

    Report Number
    1061932-2013-00179
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K964988
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BEC CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING THE LEAK OVER THE TELEPHONE. CTS INSTRUCTED THE CUSTOMER TO MANUALLY BLEACH AND RINSE THE RED BLOOD COUNT (RBC) AND WHITE BLOOD COUNT (WBC) BATHS DRAIN AND THE PROBE WIPE. AFTER THIS WAS PERFORMED, THE CUSTOMER RAN CONTROLS IN THE INSTRUMENT WITHOUT ANY LEAKS. ISSUE WAS RESOLVED. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IS NOT LIMITED TO, WEARING PROTECTIVE EYE WEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS INSTRUMENT OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING A LEAK AT THE PROBE AND BATHS OF THE COULTER ACT 8/10 ANALYZER. THE VOLUME OF THE LEAK WAS A FEW MLS AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT. NO ONE CAME IN CONTACT WITH THE FLUID. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63441 COULTER AC*T 8/10 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER AC*T 8/10 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1