BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5DIFF AUTOLOADER (AL)

    MDR report key: 2297250 · Received October 15, 2011

    Report

    Report Number
    1061932-2011-01561
    Event Type
    Malfunction
    Date Received
    October 15, 2011
    Date of Event
    September 14, 2011
    Report Date
    September 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030291
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CURRENT PLT THRESHOLD AND GAIN SETTINGS ARE NOT SET APPROPRIATELY TO TRIGGER THE SCL FLAG. TO CORRECT THIS ISSUE, THE PLT THRESHOLD SETTING WILL BE CHANGED FROM 390 TO 350 MILLIVOLTS AND THE LATEX PARTICLE GAIN SETTINGS WILL BE UPDATED FROM 107 TO 115 TO ENABLE THE FLAG TO BE TRIGGERED APPROPRIATELY AND IN ACCORDANCE WITH PRODUCT LABELING SPECIFICATIONS. THE IMMEDIATE ROOT CAUSE OF THIS ISSUE IS THAT THE PLT THRESHOLD AND LATEX PARTICLE GAIN SETTINGS FOR THE PLTS WERE NOT SET CORRECTLY IN MANUFACTURING TO ENABLE THE SCL FLAG TO TRIGGER APPROPRIATELY. (B)(4).

    Description of Event or Problem · 1

    AN ORIGINAL EQUIPMENT MANUFACTURER (OEM) (B)(4) DISCOVERED DURING IN-HOUSE TESTING THAT THE COULTER ACT 5DIFF AUTOLOADER (AL) DOES NOT TRIGGER THE "SCL" (SMALL CELL) FLAG FOR THE PLATELET (PLT) PARAMETER AS EXPECTED PER PRODUCT LABELING SPECIFICATIONS ((B)(4)) WHEN THE APPROPRIATE CONDITIONS WERE MET. THE PRESENCE OF VERY SMALL CELLS, DEBRIS, MICRO-BUBBLES OR ELECTRONIC NOISE IN THE 2FL AND 3FL REGION ON THE PLT HISTOGRAM COULD INTERFERE WITH THE PLATELET COUNT WITHOUT TRIGGERING THE SCL FLAG AND POTENTIALLY CAUSING AN ERRONEOUS ELEVATED PLT COUNT. THIS ISSUE WAS DISCOVERED IN-HOUSE. NO ACTUAL PATIENT RESULTS WERE PRODUCED. NO ERRONEOUS RESULTS HAVE BEEN REPORTED AND THERE HAS BEEN NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT 5DIFF AUTOLOADER (AL) COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. ACT 5DIFF AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1