BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3646245 · Received February 25, 2014

    Report

    Report Number
    1061932-2014-00423
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 30, 2014
    Report Date
    January 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    2050012-0730/2018-011-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) DISCOVERED ONGOING TOTAL COMPLETE BLOOD COUNT (CBC) VOTE-OUTS ERRORS AND RED BLOOD CELL (RBC) PUMP MOVEMENT NOT VERIFIED ERRORS. THE FSE INSTALLED A NEW CBC MOTOR CONTROLLER BOARD, THE GENERIC CARD THAT CONTROLS THE MOTOR CONTROLLER BOARD, A NEW RBC PUMP AND BATH AND ATTEMPTED TO ISOLATE THE ISSUE BY SWAPPING THE CBC AND VSCN (SIGNAL CONDITIONER ANALYZER) SCA BOARDS, BUT WAS UNSUCCESSFUL. ON (B)(4) 2014, THE FSE INSTALLED A NEW CBC TRANSDUCER BOARD. AFTER INSTALLATION, THE WHITE BLOOD CELL (WBC) APERTURE #3 WAS REPORTING LOW RESULTS UNLIKE THE OTHER TWO APERTURES. THE FSE SWITCHED THE APERTURE CONNECTIONS TO ELIMINATE THE WBC BATH. THE FSE RE-INSTALLED THE CBC TRANSDUCER BOARD. ON (B)(4) 2014, THE FSE REPLACED THE BLOOD SAMPLING VALVE (BSV) ASSEMBLY AND DID NOT WITNESS RBC PUMP ERRORS OR ERRATIC PLATELET COUNTS. BUT THE FSE NOTED THE WBC COUNTS WERE VOTING OUT EVERY SAMPLE ON APERTURE #3 (PARTIAL VOTE-OUT). THE FSE THEN SWITCHED THE CBC SCA CARD AND THE VCSN SCA CARD. THE WBC COUNT IMPROVED BUT WAS RECEIVING PLATELET CLUMP FLAGS ON EVERY SAMPLE AND NO NRBC COUNTS, WITH A SCA A/D SYSTEM ERROR. ON (B)(4) 2014, THE FSE REPLACED THE FAULTY SCA CARD AND PERFORMED ALL SYSTEM VERIFICATIONS. THE FSE ALSO ADJUSTED CALIBRATION FACTORS. THE FSE NOTED AFTER REPLACING THE BLOOD SAMPLING VALVE (BSV), THE RBC PUMP MOVEMENT ERRORS AND PLATELET COUNTS STABILIZED. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED PERFORMANCE SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. THE CUSTOMER-SUPPLIED RAW DATA FILES AND HISTOGRAMS WERE REVIEWED. NO OBVIOUS ABNORMALITY WAS FOUND TO DETERMINE THE CAUSE OF THE FAILURE. HOWEVER, COMPARISON OF THE PLATELET HISTOGRAMS (PRINTOUT) BETWEEN THE BAD RESULT AND THE GOOD RESULT (FROM ANOTHER INSTRUMENT) SHOWED A CONSISTENT PATTERN. THE HISTOGRAM OF THE BAD RESULT TENDS TO HAVE A HIGHER TAKE-OFF, INDICATING MORE DEBRIS INTERFERENCE. THE NATURE OF THE LOW END INTERFERENCE CANNOT BE DETERMINED FROM THE DATA. IN CONCLUSION, THE SPECIFIC FAILURE MODE FOR THE ERRONEOUS PLATELET RESULTS IS UNKNOWN BUT ATTRIBUTED TO THE BSV ASSEMBLY. THE WBC VOTE-OUTS ISSUE WAS RESOLVED BY REPLACING THE SCA CARD. BECKMAN COULTER CONTINUES TO TRACK AND TREND ANY INCIDENT RELATED TO THIS ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING TOTAL CBC VOTE OUTS AND RBC PUMP MOVEMENT NOT VERIFIED SYSTEM ERRORS INVOLVING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. THE CUSTOMER THEN REANALYZED PATIENTS' SAMPLES ON AN ALTERNATE INSTRUMENT AND DISCOVERED 14 SAMPLES HAD INCORRECT, UN-FLAGGED PLATELET COUNTS. THESE RESULTS WERE RELEASED FROM THE LABORATORY. THERE HAS BEEN NO REPORT OF PATIENT CONSEQUENCE OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. THE CUSTOMER INDICATED ALL THE RESULTS WERE IN OR NEAR THE EXPECTED RANGES. REVIEW OF THE DATA INDICATES THE SAMPLES RECOVERED HIGH PLATELET COUNTS (COMPARED TO AN ALTERNATE UNICEL DXH 800 ANALYZER) WITH NO INSTRUMENT GENERATED MESSAGES. ALL OTHER PARAMETERS WERE COMPARABLE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115662 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1