BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT 5 DIFF CAP PIERCE HEMATOLOGY ANALYZER

    MDR report key: 2223663 · Received August 25, 2011

    Report

    Report Number
    1061932-2011-01302
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN EDTA TUBES. NO OTHER DETAILS WERE PROVIDED. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND WERE WITHIN THE ESTABLISHED RANGES. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN THE QC SPECIFICATIONS. ONLY ONE PATIENT SAMPLE WAS PROVIDED WITH MANUAL DIFFERENTIAL RESULTS THAT SHOWED NO PRESENCE OF BASOPHILS. THE SAME SAMPLE RUN ON THE INSTRUMENT SHOWED BASOPHILS OF 6.4% WITH AN OPERATOR DEFINED BASOPHILIA FLAG. WBC RESULTS WERE NOT IMPACTED. TWO OTHER SAMPLES PROVIDED SHOWED ELEVATED BASOPHIL RESULTS WITH OPERATOR DEFINED BASOPHILIA FLAG, BUT DID NOT INCLUDE MANUAL DIFF RESULTS. ON (B)(4) 2011, BEC FIELD SERVICE ENGINEER (FSE) FOUND CRYSTAL FORMATION ON THE WBC LYSE PICKUP TUBE. WBC LYSE TUBING WAS FLUSHED AND THE WBC LYSE REAGENT WAS REPLACED ALONG WITH VL11 (VALVE). THE FSE RAN QC AND ALL RESULTS WERE WITHIN THE RANGE. THE FSE RAN PATIENT SAMPLES TO CONFIRM. NO MORE BASOPHILIA FLAGS WERE OBSERVED. THE ROOT CAUSE FOR THE ELEVATED BASOPHIL RESULTS CAN BE ATTRIBUTED TO THE CRYSTAL FORMATION ON THE WBC LYSE PICKUP TUBING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT COULTER ACT 5DIFF CAP PIERCE HEMATOLOGY ANALYZER INTERMITTENTLY GENERATED HIGH BASOPHIL (BA) RESULTS WITHOUT INSTRUMENT GENERATED FLAGS FOR THREE PATIENT SAMPLES. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. NO BASOPHILS WERE SEEN ON THE SLIDES FOR THE PATIENTS. THE RESULTS ARE SHOWN IN THE ATTACHED FILE. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® ACT 5 DIFF CAP PIERCE HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. ACT 5DIFF CP NA

    Patients

    Seq Age Sex Outcome Treatment
    1