BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER ACT 5DIFF CAP PIERCE

    MDR report key: 3933391 · Received July 14, 2014

    Report

    Report Number
    1061932-2014-01656
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 16, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042173
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND DISCOVERED SALT BUILDUP ON THE REAR SIDE OF THE FLOWCELL AS A RESULT OF A CRACK IN THE FLOWCELL. THE FSE ORDERED A NEW REPLACEMENT PART TO BE SENT TO THE CUSTOMER TO ADDRESS THE ISSUE. THE CAUSE OF THE DISCREPANT RESULTS IS LIKELY ATTRIBUTED TO THE CRACKED FLOWCELL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUS DIFFERENTIAL RESULTS FOR APPROXIMATELY TEN (10) PATIENT SAMPLES FROM THE COULTER ACT 5DIFF CAP PIERCE. THE CUSTOMER STATED THAT THE INSTRUMENT GENERATED R FLAGS FOR THE DIFFERENTIAL RESULTS AND SUBOPTIMAL SCATTERGRAMS. R FLAGS ARE GENERATED TO ALERT THE CUSTOMER TO REVIEW THE RESULTS. THE CUSTOMER PROVIDED ONLY FOUR (4) PATIENT SAMPLE RESULTS FOR REVIEW. A REVIEW OF THE PATIENT RESULTS INDICATES THAT THE INITIAL SAMPLE RUNS FOR THE FOUR (4) PATIENTS GENERATED HIGHER LYMPHOCYTE (LY) AND LOWER NEUTROPHIL (NE) RESULTS ALONG WITH INSTRUMENT GENERATED FLAGS WHEN COMPARED TO THE MANUAL DIFFERENTIAL RESULTS WHICH THE CUSTOMER CONSIDERED CORRECT. PATIENT #4 ALSO SHOWED HIGHER MONOCYTE (MO) AND EOSINOPHIL (EOS) RESULTS WHEN COMPARED TO THE MANUAL DIFFERENTIAL RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. QUALITY CONTROL RESULTS PRIOR TO THE EVENT WERE WITHIN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409616 COULTER ACT 5DIFF CAP PIERCE COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1