BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® AC*T DIFF ANALYZER

    MDR report key: 3203187 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01272
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND CONFIRMED A SMALL LEAK AT THE PROBE AND THAT THE INSTRUMENT WAS GENERATING PLT (PLATELET) BACKGROUND FAILURES. THE FSE INDICATED THAT THE DUAL FILTERS REQUIRED REPLACEMENTS BUT THE CUSTOMER DID NOT HAVE ANY FILTERS IN INVENTORY. THE FSE REPLACED THE DILUENT FILTERS TO RESOLVE THE LEAK BUT DISCOVERED EXCESSIVE BUILDUP ON THE SYRINGES. THE FSE PROCEEDED TO REPLACE THE DILUENT AND SAMPLE SYRINGES AND DECONTAMINATED THE INSTRUMENT TO RESOLVE THE PLATELET BACKGROUND FAILURES. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE DUAL DILUENT FILTERS AND FAILURE MODE OF THE PLT BACKGROUND FAILURES IS ATTRIBUTED TO EXCESSIVE BUILDUP ON THE SYRINGES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FAILING PLT (PLATELET) BACKGROUNDS AND NOTICED WHITE CRYSTALLIZATION NEAR THE TRIPLE SYRINGE ASSEMBLY AND DROPS OF FLUID AT THE PROBE WIPE DURING STARTUP INVOLVING THE COULTER ACT DIFF ANALYZER. THE CUSTOMER INDICATED THAT APPROXIMATELY 3 DROPS OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302126 COULTER® AC*T DIFF ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1