BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2262843 · Received September 26, 2011

    Report

    Report Number
    1061932-2011-01547
    Event Type
    Malfunction
    Date Received
    September 26, 2011
    Date of Event
    August 21, 2011
    Report Date
    August 24, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER INC BEC) IN REGARDS TO THE LH750 INSTRUMENT GENERATED RETIC ABSOLUTE # RESULT IN UNITS OF 106 / ?L UNITS AFTER THE WORKSTATION WAS RE-IMAGED. THE CUSTOM EXPECTED REPORTING UNITS FOR RETIC ABSOLUTE NUMBER TO BE IN 103 / ?L. THE LIS APPARENTLY DID NOT HAVE A CONSISTENCY CHECK FOR REPORTING UNITS AND WHEN RESULTS WERE SENT TO (B)(4) LIS IN 106 / ?L UNITS, THE RETIC RESULTS WERE MISINTERPRETED AND ROUNDED DOWN AS ZERO (0.0) FOR RETIC #. (EXAMPLE: 27.2 103 / ?L WAS GETTING REPORTED BY THE INSTRUMENT AS 0.0272 106 / ?L AND LIS ROUNDING DOWN.) ERRONEOUS RESULTS WERE REPORTED OUT OF THE LAB. THE WORKSTATION WAS RE-IMAGED ON (B)(6) 2011 AND US1 DEFAULT RANGE OF 106 / ?L WAS LEFT IN USE FOR RETIC #. THE RETIC CONTROL SUMMARY SCREEN SHOWED ABSOLUTE RETIC COUNTS AS 103 / ?L WHILE INDIVIDUAL CONTROL RUN PRINTOUTS WERE SHOWING 106 / ?L. PATIENT PRINTOUTS WERE NOT PROVIDED, ONLY CONTROL DATA PROVIDED WHICH VERIFIED THE CONTROL RUN AND SUMMARY UNITS DIFFERENCE. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS CF. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. CALL CENTER PERSONNEL ASSISTED CUSTOMER TO CHANGE REPORTING UNITS. ROOT CAUSE IS UNKNOWN, HOWEVER, IT IS POSSIBLE THAT THE EVENT OCCURRED DURING THE WORKSTATION RE-IMAGING ON (B)(6) 2011. THE INSTRUMENT WAS SHOWING ABSOLUTE COUNT UNIT OF MEASURE (106 / ?L) NEXT TO THE COUNTS ON INSTRUMENT DISPLAY AND PATIENT PRINTOUTS. ERRONEOUS RESULTS WERE NEVER INCORRECTLY REPORTED BY THE INSTRUMENT, BUT RATHER EXPRESSED IN AN UNEXPECTED REPORTING UNIT FOR RETIC ABSOLUTE (103 / ?L).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1