BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2843108 · Received November 21, 2012

    Report

    Report Number
    1061932-2012-02754
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE THE INCIDENT AND WERE WITHIN SPECIFICATIONS. NO CONTROLS WERE RUN AFTER THE INCIDENT. PER THE INFORMATION PROVIDED, THE BLAST FLAGGING PREFERENCE WAS SET AT MID-LEVEL FOR BOTH INSTRUMENTS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2012 FOR THIS EVENT. THE FSE VERIFIED THE FLOW CELL BY THE USUAL TEST AND INSPECTION PROCESS WITH CONTROLS AND LATRON. THE FSE ALSO VERIFIED THAT THE INSTRUMENT WAS ANALYZING ABOVE 7900 CELLS ON WHOLE BLOOD SPECIMENS. PUMP VOLUMES ON LYSE AND STABILYSE WERE ALSO CHECKED. FAILURE MODE IS CURRENTLY UNKNOWN. THE FOLLOWING MDRS ARE ASSOCIATED WITH THIS EVENT DOCUMENTED IN THIS REPORT: 1061932-2012-02752, 1061932-2012-02753.

    Additional Manufacturer Narrative · 1

    THE RAW DATA ANALYSIS INDICATED THAT THE HISTOGRAMS SHOW A SLIGHTLY TILTED NEUTROPHIL POPULATION, A SLIGHTLY HIGH MONOCYTE PERCENT, AND SCATTERED NOISY EVENTS IN THE HIGH DIRECT CURRENT (DC) AREA. HOWEVER, THESE CHARACTERISTICS WERE NOT SIGNIFICANT ENOUGH FOR THE ALGORITHM TO SET A BLAST FLAG FOR THE SAMPLES INVOLVED IN THIS EVENT. FOR THE PATIENT SAMPLE DOCUMENTED IN THIS REPORT THE ALGORITHM SET AN NUCLEATED RED BLOOD COUNT (NRBC) FLAG AT ALL SENSITIVITY LEVELS. FAILURE MODE (FINAL INVESTIGATION): THE CHARACTERISTICS OF THE PATIENT SAMPLES WERE NOT SIGNIFICANT ENOUGH FOR THE ALGORITHM TO SET A BLAST FLAG.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT BLAST SUSPECT FLAGS WERE NOT OBTAINED ON TWO (2) DIFFERENT ANALYZERS - COULTER LH 780 HEMATOLOGY ANALYZER (SERIAL # (B)(4)) AND COULTER LH 750 HEMATOLOGY ANALYZER (SERIAL # (B)(4)) , ON TWO (2) SEPARATE DAYS ((B)(6) 2012), FOR ONE PATIENT WITH BLASTS CELLS IDENTIFIED BY MANUAL SMEARS. THIS REPORT DOCUMENTS THE RESULTS GENERATED BY THE LH 750 INSTRUMENT (SERIAL # (B)(4)) ON (B)(6) 2012. THE CUSTOMER INDICATED THAT NO BLAST FLAGGING MESSAGES WERE GENERATED. IN ADDITION, AN ERRONEOUS MONOCYTE (MO%) RESULT WAS ALSO OBTAINED COMPARED TO THE MANUAL RESULTS. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT SECTION OF THIS REPORT. THE RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, THERE WAS NO IMPACT TO PATIENT TREATMENT.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1