BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF ANALYZER

    MDR report key: 3250909 · Received July 29, 2013

    Report

    Report Number
    1061932-2013-01586
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. THE FSE INDICATED THAT HE WAS NOT ABLE TO CONFIRM AN ACTIVE LEAK. HOWEVER, THE FSE DID CONFIRM THE BACKGROUND COUNT WAS FAILING FOR PLATELETS (PLT). THE FSE PERFORMED A DECONTAMINATION PROCEDURE WHICH INCLUDED FLUSHING OUT OLD REAGENTS, BLEACHING THE REAGENT PICKUP TUBES, BATHS, PROBE, DILUENT RESERVOIR, AND WASTE TUBING. THE FSE CONNECTED ALL NEW REAGENTS TO THE ACT DIFF ANALYZER FOLLOWING THE DECONTAMINATION PROCEDURE. THIS PROCEDURE RESOLVED THE HIGH PLT BACKGROUND PROBLEM. THE FSE COULD NOT CONFIRM AN ACTIVE LEAK. THE FAILURE MODE RELATED TO THE PLT FAILING THE BACKGROUND WAS ATTRIBUTED TO CONTAMINATION. BECKMAN INTERNAL IDENTIFIER NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT APPROXIMATELY 2 DROPS OF LIQUID LEAKED FROM THE PROBE AND ONTO THE COUNTER FOLLOWING A STARTUP IN THE COULTER AC*T-DIFF ANALYZER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED THAT PLATELETS (PLT) FAILED THE BACKGROUND. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL/RISK MANAGEMENT PLAN IN PLACE AT THE FACILITY. THE OPERATOR WAS WEARING GLOVES AND EYEWEAR AT THE TIME OF THE INCIDENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION. THERE WAS NO IMPACT TO PATIENT RESULTS. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352939 COULTER® ACT DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA

    Patients

    Seq Age Sex Outcome Treatment
    1