BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3051650 · Received April 10, 2013

    Report

    Report Number
    1061932-2013-00609
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: GHT SCATTER PREAMPLIFIER. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED GENERATING NON-NUMERIC, INSTRUMENT-GENERATED, INCOMPLETE RESULT FLAGS (RETIC DOTS) FOR RETIC PARAMETERS INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. NO DATA IS AVAILABLE FOR THIS EVENT AS THERE WAS NO IMPACT TO PATIENT RESULTS. THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED THAT THE RINSE LINE FOR THE RETIC CHAMBER HAD A SMALL CUT. THE FSE STATED THAT THE INSTRUMENT DID NOT LEAK FLUID THROUGH THE CUT TUBING. THE FSE REPLACED THE TUBING BUT THE INSTRUMENT STILL GENERATED RETIC DOTS. THE FSE REPLACED THE LIGHT SCATTER PREAMPLIFIER AND THE INSTRUMENT GAVE PROPER RETIC VALUES. LASER AND RETIC MOTOR ASSEMBLY WAS ALSO REPLACED AS A PREVENTIVE MEASURE. UPON FURTHER INSPECTION, THE FSE DISCOVERED THAT PINCH VALVE VL45 WAS BROKEN. THE BROKEN PINCH VALVE DID NOT CAUSE ANY LEAKS AND THE FSE PROCEEDED TO REPLACE THE PINCH VALVE. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. THE CAUSE OF THE RETIC DOTS CAN BE ATTRIBUTED TO THE LIGHT SCATTER PREAMPLIFIER. THE FSE STATED THAT NO RAW DATA IS AVAILABLE FOR THIS EVENT. PINCH VALVE VL45 CONTROLS THE DELIVERY OF STABILYSE TO THE DIFF MIXING CHAMBER AND MAY AFFECT RESULTS FOR DIFF PARAMETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153447 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1