BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3900972 · Received June 30, 2014

    Report

    Report Number
    1061932-2014-01457
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    January 17, 2014
    Report Date
    January 17, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE NOTICED A LEAK OF CLEANER INSIDE THE INSTRUMENT AND DISCOVERED A DEFECTIVE TUBING AT PINCH VALVE PV37. THE FSE REPLACED THE TUBING AT PV37 TO RESOLVE THE LEAK. THE FSE ALSO FOUND A SECOND ISSUE ASSOCIATED WITH A LEAK OF DILUENT INSIDE THE INSTRUMENT. THE FSE REPLACED THE TUBING FOR PINCH VALVE PV49 TO RESOLVE THE SECOND LEAK. THE FSE THEN DISCOVERED A THIRD LEAK ASSOCIATED WITH THE PROBE WIPE LEAKING ON THE FRONT OF THE ANALYZER. THE FSE FOUND THE PROBE WAS BENT THEREBY NOT ALLOWING THE PROBE WIPE TO COMPLETE THE FULL LENGTH OF TRAVEL TO RINSE THE PROBE. IN ADDITION, THERE WAS AN INCORRECTLY PLACED TUBING ON PINCH VALVE PV42 CAUSING EXCESSIVE DILUENT TO LEAK FROM THE PROBE RINSE BLOCK. THE FSE STRAIGHTENED THE BENT PROBE AND REPLACED THE INCORRECTLY PLACED TUBING AT PV42 TO RESOLVE THE LEAK FROM THE PROBE. THE FSE WAS THEN INFORMED BY THE CUSTOMER THAT THE INSTRUMENT GENERATED RED BLOOD CELL (RBC) AND MEAN CORPUSCULAR VOLUME (MCV) VOTE OUTS (NON-NUMERICAL RESULTS). THE FSE PROCEEDED TO REPLACE THE O-RINGS AND RBC APERTURE TO RESOLVE THE RBC/MCV VOTE OUTS. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT. THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK IN CONNECTION WITH THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING A BIASED LOW RED BLOOD CELL (RBC) PARAMETER FROM THE LH 500 HEMATOLOGY ANALYZER FOR THE COULTER 5C CELL CONTROL WHEN PERFORMING CALIBRATION WITH THE COULTER S-CAL CALIBRATOR KIT, AS COMPARED TO THE RBC ASSAY VALUE ON THE COULTER 5C CELL CONTROL. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. CUSTOMER TECHNICAL SPECIALIST (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING OVER THE TELEPHONE AND NOTED THE RBC CALIBRATION FACTOR HAS BEEN CALCULATED AND ADJUSTED TO RECOVER WITHIN THE ASSIGNED RANGE FOR THE 5C CONTROLS. THE CUSTOMER REQUESTED FOR SERVICE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379935 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1