BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH750 HEMATOLOGY ANALYZER

    MDR report key: 2211711 · Received August 5, 2011

    Report

    Report Number
    1061932-2011-01007
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    October 9, 2009
    Report Date
    October 12, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. DURING THE INITIAL PHONE CONTACT ON (B)(6) 2009 IT WAS DETERMINED THAT THE CUSTOMER FAILED TO RUN A PRIMING SAMPLE AFTER RETIC-C CONTROLS WERE PROCESSED. THE CUSTOMER HAD REC'D THE (B)(4) LETTER REGARDING A POTENTIAL CARRYOVER ISSUE IF A PRIMING SAMPLE IS NOT PROCESSED AFTER CONTROLS; HOWEVER, IN THIS CASE THE CUSTOMER DID FOLLOW THESE INSTRUCTIONS AND A PT SAMPLE WAS CONTAMINATED. ON (B)(6) 2009, A FIELD SERVICE ENGINEER (FSE) VISITED THE SITE TO ASSESS THE LH750 ANALYZER. HE FLUSHED THE VENT SYSTEM AND CHANGED TUBING, NOTING DRY BLOOD AND WETNESS ON THE STRIPPER PLATE, AND REPLACED OTHER COMPONENTS. THE FSE CYCLED THREE EMPTY TUBES WERE CLEAN AND DRY. A PT SAMPLE WAS CYCLED TO CHECK FOR CARRYOVER AND RESULTS WERE SATISFACTORY. THE ROOT CAUSE OF THE CONTAMINATION OF THE PT SAMPLE IS UNK, THOUGH MAY BE RELATED TO THE USER NOT FOLLOWING INSTRUCTIONS AND/ OR THE PARTS CHANGED AND SERVICE PERFORMED DURING THE FSE VISIT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBSERVATION OF ABNORMAL CELLS (THOUGH TO BE NUCLEATED RED CELLS) UPON MICROSCOPIC REVIEW OF A SLIDE PREPARED BY THE SLIDEMAKER COMPONENT OF THE LH750 HEMATOLOGY ANALYZER. THIS BLOOD SAMPLE WAS FROM A NORMAL PT WHICH WAS PROCESSED ON THE ANALYZER ABOUT FIVE TO TEN MINS AFTER 5C AND RETIC-C QUALITY CONTROL SPECIMENS WERE RUN ON THE EVENING SHIFT. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY AS THE SLIDE WAS HELD FOR FURTHER REVIEW. A SLIDE PREPARED MANUALLY THE NEXT DAY FROM THE SAME TUBE SHOWED THE SAME ABNORMAL CELLS. IT APPEARED THAT THE PT SAMPLE HAD BECOME CONTAMINATED BY THE INSTRUMENT ON (B)(6) 2009 WITH AVIAN RED BLOOD CELLS, A COMPONENT OF THE RETIC-C QUALITY CONTROL PRODUCT. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK