BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780

    MDR report key: 3241498 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01528
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IS PROVIDING A CORRECTION FOR MDR #: 1061932-2013-01528. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED AIR BUBBLES IN THE RED BLOOD CELL (RBC) DILUENT DISPENSER WHICH HAD CAUSED THE HIGH RBC RESULTS REPORTED. THE FSE REPLACED THE DISPENSER, RESOLVING THE HEMATOCRIT AND HEMOGLOBIN (H&H) ISSUES. THE FSE ALSO OBSERVED DEBRIS ON THE RETIC SHEAR VALVE AND PROCEEDED TO CLEAN THE SHEAR VALVES AND REPLACE THE PILOT ACTUATOR AT VALVE VL89 TO RESOLVE THE ISSUE. THE RBC DISPENSER AND THE SHEAR VALVE ISSUES WERE UNRELATED. CLEANING OF THE SHEAR VALVES, PER IFU, IS NOT A ROUTINE PROCEDURE PERFORMED BY CUSTOMER WITHOUT INSTRUCTIONS FROM A BECKMAN COULTER REPRESENTATIVE. FAILURE MODE WAS RELATED TO BUBBLES IN THE RBC DILUENT DISPENSER (PM2). ANOTHER FAILURE MODE WAS ATTRIBUTED TO THE PILOT ACTUATOR AT VL89.

    Additional Manufacturer Narrative · 1

    ALL QUALITY CONTROL (QC) RESULTS WERE WITHIN SPECIFICATION. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND OBSERVED AIR BUBBLES IN THE RBC DILUENT DISPENSER WHICH HAD CAUSED THE HIGH RBC RESULTS REPORTED. THE FSE INDICATED THAT HE REPLACED A DEFECTIVE RED BLOOD CELL (RBC) DILUENT DISPENSER TO ADDRESS ISSUES OF HIGH RBC RESULTS. THE FSE ALSO OBSERVED DEBRIS ON THE RETIC SHEAR VALVE AND PROCEEDED TO CLEAN THE SHEAR VALVES AND REPLACE PILOT ACTUATOR TO RESOLVE THE ISSUE. THE RBC DISPENSER AND THE SHEAR VALVE ISSUES WERE UNRELATED. THE PILOT ACTUATOR WAS NOT IDENTIFIED AS A MALFUNCTION, IT WAS REPLACED AS AN INCIDENTAL MAINTENANCE. FAILURE MODE WAS ATTRIBUTED TO THE BUBBLES IN THE RBC DILUENT DISPENSER. ANOTHER FAILURE MODE WAS RELATED TO MATERIAL BUILDUP ON THE RETIC SHEAR VALVE.

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IS PROVIDING A CORRECTION FOR MDR #: 1061932-2013-01528. THIS FOLLOW-UP REPORT IS TO CORRECT THE ORIGINAL SUBMISSION: THE FILE ATTACHMENT WAS ATTACHED IN ERROR. THE REPORT SHOULD HAVE NO ATTACHMENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEY OBTAINED HIGHER RED BLOOD COUNT (RBC) RESULTS FROM THE COULTER LH 780 ANALYZER COMPARED WITH RESULTS RECOVERED ON ANOTHER INSTRUMENT. THE CUSTOMER ALSO REPORTED HEMOGLOBIN AND HEMATOCRIT (H AND H ) CHECK FAILURES. PATIENT DATA WAS NOT SUPPLIED. THE FIELD SERVICE ENGINEER (FSE) PROVIDED AN EXAMPLE OF ONE PATIENT RESULTS WHERE THE INSTRUMENT REPORTEDLY RECOVERED A HIGHER RBC RESULTS THAN A RERUN OF THE SAME SAMPLE ON ANOTHER INSTRUMENT. THE ORIGINAL RESULT WAS 4.50 X 10^6 CELLS/¿L, BUT WHEN REPEATED ON ANOTHER INSTRUMENT A RESULT OF 3.75 X 10^6 CELLS/¿L WAS OBTAINED. THE RERUN WAS CONSIDERED CORRECT. THE FSE STATED THAT THERE WERE NO PRINTOUTS AVAILABLE FOR REVIEW AND AS SUCH INSTRUMENT FLAGS AND MESSAGES CANNOT BE REVIEWED. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340968 COULTER® LH 780 COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1