BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOW CYTOMETERY (FC500) TETRACXP SYSTEM FOR THE CYTOMICS FC 500

    MDR report key: 2020842 · Received March 16, 2011

    Report

    Report Number
    1061932-2011-00139
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 11, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANTIBODY REAGENTS USED WERE CD5-PE (IM0469U) AND CD23-ECD (IM3609U), CD56-PE (IM2073U), CD3-ECD (IM2705U), DAKO KAPPA LIGHT CHAINS/FITC + LAMBDA LIGHT CHAINS/RPE (FR 481), AND CD20-ECD (IM3607U). INFORMATION REGARDING RUNNING OF CONTROLS BEFORE AND AFTER THE EVENT WAS NOT PROVIDED FOR THIS INVESTIGATION. SERVICE WAS NOT REQUESTED. A BCI FIELD SYSTEM SPECIALIST (FSS) ADVISED THE CUSTOMER THAT THE INSTRUMENT (FC 500 (B)(4)) SHOULD NOT BE USED FOR CLINICAL SAMPLES UNTIL REPAIRS ARE MADE. ON (B)(4) 2011, THE CUSTOMER DECIDED TO SWAP THE HV-DAC AND CYTO-TRANSPROCESSOR BOARDS FROM THEIR OTHER FC500. TH ISSUE HAS NOT REOCCURRED. A BCI CYTOMETRY SERVICE MANAGER CONTACTED THE CUSTOMER TO DISCUSS POTENTIAL ISSUE(S) WITH THE CUSTOMER PERFORMING THEIR OWN REPAIRS. THE CUSTOMER DECLINED SERVICE AND CONTINUES TO SWAP BOARDS BETWEEN INSTRUMENTS WHILE TROUBLESHOOTING EVENTS. AS OF (B)(4) 2011, THE CUSTOMER HAS NOT REQUESTED SERVICE OR ORDERED BOARDS TO REPAIR THE INSTRUMENT; HENCE NO PARTS ARE BEING RETURNED TO BCI FOR EVALUATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO CD5-PE SIGNAL WAS ABERRANTLY ACQUIRED AS A CD23-ECD SIGNAL DURING THE ANALYSIS OF A LEUKEMIA-LYMPHOMA BONE MARROW SPECIMEN. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY. THE ISSUE WAS DISCOVERED UPON REVIEW OF THE RESULTS FROM THE FC 500. UPON RERUNNING THE SAME TUBE ON THE SAME INSTRUMENT USING THE SAME PROTOCOL AND SETTINGS, THE ERROR DID NO REOCCUR. NO REPORTS OF DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOW CYTOMETERY (FC500) TETRACXP SYSTEM FOR THE CYTOMICS FC 500 AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. FC 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1