BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750

    MDR report key: 872676 · Received June 27, 2007

    Report

    Report Number
    1061932-2007-00038
    Event Type
    Other
    Date Received
    June 27, 2007
    Date of Event
    May 30, 2007
    Report Date
    June 27, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS REVIEWED WITH LIMITED INFORMATION: A) PRE-ANALYTICAL SAMPLE HANDLING AND THE SYSTEM INFORMATION WAS NOT PROVIDED. B) SERVICE INFORMATION WAS NOT SUPPLIED. BASED ON RAW DATA ANALYSIS: A) THE REASON FOR DIMORPHIC REDS FLAG IS THAT THE SAMPLE HAS A RED CELL DISTRIBUTION WIDTH (RDW) VALUE OF 29.2. THE INSTRUMENT FLAGS DIMORPHIC REDS WHENEVER THE RDW IS OVER 25, IN ADDITION TO THE DETECTION OF DOUBLE POPULATIONS IN RBC HISTOGRAM. THE INDICATES THE POSSIBLE OVERLAPPED RBC POPULATIONS. B) BASED ON THE PLT HISTOGRAM, THERE ARE SOME INDICATIONS OF SMALL RBC INTERFERENCE ON PLT. VERY SMALL RED CELLS AND RED CELL FRAGMENTS ARE A KNOWN INTERFERING SUBSTANCE. A MALFUNCTION WILL BE ASSUMED FOR THE PURPOSE OF THIS REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING AN ERRONEOUSLY HIGH PLATELET (PLT) RESULT FROM A SINGLE PATIENT SAMPLE THAT WAS GENERATED BY THE COULTER LH 750 INSTRUMENT. A PATIENT SAMPLE WAS TESTED FOR PLT AND A RESULT OF 651.08 X 10 TO THE POWER OF 3 CELLS/UL WAS OBTAINED. THE RESULT WAS ACCOMPANIED BY THE INSTRUMENT GENERATED "DIMORPHIC REDS*" MESSAGE AND A "H AND H**"CHECK FAILURE FLAG. PER CUSTOMER, A MANUAL SMEAR PERFORMED ON THIS SAMPLE RECOVERED APPROXIMATELY 1/2 OF THE INSTRUMENT PLT RESULT AND DID NOT SHOW ANY "DIMORPHIC REDS". THERE WAS NO CHANGE TO PATIENT TREATMENT RELATED TO THIS EVENT. *"DIMORPHIC REDS" - "THE INSTRUMENT FLAGS DIMORPHIC RED WHENEVER THE RDW IS OVER 25 IN ADDITION TO THE DETECTION OF DOUBLE POPULATIONS IN RBC HISTOGRAM. THAT INDICATES THE POSSIBLE OVERLAPPED RBC POPULATIONS". **"H AND H CHECK FAILURE"- "HCT<[(HGB*3)-3] OR HCT.[(HGB*3)+3]"

    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 YR