BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 2944505 · Received February 5, 2013

    Report

    Report Number
    1061932-2013-00137
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE BEC CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER VIA THE TELEPHONE IN BLEACHING THE PATHWAY FROM THE PROBE RINSE BLOCK (PROBE WIPE) TO THE VACUUM ISOLATOR CHAMBER (VIC) TO RESOLVE THE LEAK. AFTER BLEACHING NO FURTHER LEAKS WERE OBSERVED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. PER LABELING; "REPLACE THE PROBE WIPE WHEN IT IS DEFECTIVE OR PLUGGED. IF FLUID DRIPS FROM THE PROBE WIPE BUT VACUUM IS GOOD AND THE INSTRUMENT WORKS, THEN THE PROBE WIPE IS PROBABLY DEFECTIVE (OR PLUGGED)". "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 IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. FAILURE MODE OF THIS EVENT WAS PLUGGED PROBE RINSE BLOCK (PROBE WIPE). (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT LESS THAN 3CC CLEAR FLUID LEAKED FROM THE PROBE RINSE BLOCK (PROBE WIPE) INSIDE THEIR COULTER ACT DIFF ANALYZER AND ONTO THE TABLETOP. THE CUSTOMER WAS USING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND GLASSES AT THE TIME OF THIS EVENT. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. NO MEDICAL TREATMENT WAS NEEDED. AN EXPOSURE CONTROL PLAN IS IN PLACE AT HIS FACILITY. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT. THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49354 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1