BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS® FC500 FLOW CYTOMETER SYSTEM

    MDR report key: 3519218 · Received December 13, 2013

    Report

    Report Number
    1061932-2013-02827
    Event Type
    Malfunction
    Date Received
    December 13, 2013
    Date of Event
    November 18, 2013
    Report Date
    November 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS RUNNING PATIENT SAMPLES TO BE ANALYZED FOR LEUKEMIA/ LYMPHOMA, A NON IVD (IN VITRO DIAGNOSTIC) APPLICATION. THE CUSTOMER USES THE FC500 FLOW CYTOMETER INSTRUMENT TO RUN THE SAMPLES AND THESE ARE THEN ANALYZED USING A DIFFERENT SOFTWARE. IN THIS PARTICULAR EVENT, THE WRONG INTENSITY OF THE FL2 SIGNAL DID NOT PERMIT ACCURATE GATING SO PERCENTAGES OF MARKER EXPRESSION WERE NOT ACCURATE. THE TECHNICIAN NOTICE THAT THERE WAS SOMETHING WRONG WITH THE PATIENT SAMPLES RESULTS RAN ON THE FC500 FLOW CYTOMETER (PN: 626553, SN: (B)(4)). THE CUSTOMER DECIDED TO TEST THE SAME PATIENT SAMPLES IN A DIFFERENT FC 500 FLOW CYTOMETER INSTRUMENT AND OBTAINED THE RESULTS EXPECTED. THE CUSTOMER DID NOT REPORT RESULTS OUT OF THE LAB. THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND IDENTIFIED AN AMP CARD FAILURE ON THE FL2 PARAMETER DURING A SAMPLE RUN. THE ASSY, TARPON XL AMP AND SIGNAL CONDITIONER CARD WAS REPLACED AND INSTRUMENT WORKS AS PER SPECIFICATIONS. IDENTIFICATION OF FAILURE MODE: THE FAILURE MODE IS A DEFECTIVE ASSY, TARPON XL AMP AND SIGNAL CONDITIONER (CHANGE AD712), PN: 6707139. UPON RECUR; AN ISSUE WITH THIS BOARD CAN CAUSE ERRONEOUS RESULTS. THE ANALYTES AFFECTED ARE DEPENDENT ON THE CONFIGURATION SELECTED BY THE OPERATOR AND MAY INCLUDE CD3, CD4, CD8, CD19, CD34, CD45, AND CD56. PER BECKMAN COULTER LABELING, THE OPERATOR HAS TO FOLLOW A VERIFICATION PROTOCOL BEFORE REPORTING RESULTS.

    Description of Event or Problem · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED THAT THERE WAS AN AMP CARD FAILURE ON THE FL2 PARAMETER DURING A SAMPLE RUN WHEN USING THE CYTOMICS FC500 FLOW CYTOMETER SYSTEM. ERRONEOUS RESULTS WERE GENERATED FOR THIS EVENT. THERE WAS NO DEATH NOR INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT AS THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655168 CYTOMICS® FC500 FLOW CYTOMETER SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1