BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750

    MDR report key: 1011825 · Received March 11, 2008

    Report

    Report Number
    1061932-2008-00011
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    August 8, 2007
    Report Date
    March 11, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER CUSTOMER, THERE WAS ONE ELEVATED QC RESULT DURING THE TIMEFRAME OF THIS EVENT. SAMPLE INFO AND THE INSTRUMENT PERFORMANCE INFORMATION WERE NOT PROVIDED. AS PER CUSTOMER, QC DATA IS NO LONGER AVAILABLE BECAUSE IT MUST HAVE BEEN DELETED. ON 08/07/07, CUSTOMER REQUESTED SERVICE DUE TO INTERMITTENT PLT "R" FLAGS: THE FSE CLEANED AND ADJUSTED ROCKER BED. THE FSE VERIFIED THE INSTRUMENT WHICH WAS OPERATIONAL. THE FSE PERFORMED A STARTUP, AND RAN PERFORMANCE TESTS. THE FSE RAN AND MONITORED PLT SAMPLES. THE FSE INSTALLED NEW SPARE AIR SOLENOIDS AND REPLACED PRE-AMP. THE EVENT WAS REVIEWED WITH LIMITED INFORMATION AS PATIENT AND QC DATA WAS NO LONGER AVAILABLE SINCE THE EVENT WAS REPORTED SEVERAL MONTHS AFTER THE FACT. A CLEAR ROOT CAUSE HAS NOT BEEN DETERMINED FOR THIS EVENT. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING A HIGH PLATELET (PLT) RESULT GENERATED BY THE COULTER LH 750 ANALYZER. CUSTOMER INDICATED THAT A HIGH PLT RESULT WAS REPORTED OUT OF THE LAB FOR A PATIENT, WHO WAS ADMITTED TO THE HOSPITAL FOR FURTHER TESTING. BASED ON AVAILABLE INFORMATION, LAB PERSONNEL DISCOVERED ONE ADDITIONAL PATIENT RESULT THAT WAS ERRONEOUSLY HIGH, BUT WAS NOT REPORTED OUT AND THE PATIENT TREATMENT WAS NOT AFFECTED. PATIENT DATA IS NO LONGER AVAILABLE FOR INVESTIGATION. NO ADDITIONAL INFORMATION REGARDING THIS EVENT WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE WAS NO EFFECT TO PATIENT; HOWEVER, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA