BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2183623 · Received July 8, 2011

    Report

    Report Number
    1061932-2011-00835
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    March 19, 2008
    Report Date
    April 28, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DISCOVERED THIS EVENT WHEN THEY PERFORMED DIFFERENTIALS FOR A COMPARISON STUDY VS. A COMPETITOR ANALYZER. THE CUSTOMER USES SUSPECT MESSAGES (I.E. FLAGGING) FOR AUTO-VERIFICATION AND THE SAMPLE DATA PROVIDED WOULD NOT HAVE REQUIRED A MANUAL REVIEW OF THE BLOOD SMEAR. B5. THE INSTRUMENT WAS PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS. CONTROLS WERE RUN EVERY 8 HOURS AND WERE RUN BEFORE AND AFTER THE INCIDENT. QC WAS ACCEPTABLE. FLAGGING PREFERENCES ARE SET TO '1101' (LOW LEVEL FOR BLAST, VARIANT LYMPH, AND IMM NE 2; IMM NE 1 IS SET TO OFF). NOTE: IMM NE 1 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY BANDS. IMM NE 2 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY METAMYELOCYTES, MYELOCYTES, AND PROMYELOCYTES. RAW DATA FILES WERE REQUESTED, BUT ARE NO LONGER AVAILABLE. SERVICE WAS NOT REQUESTED FOR THE ANALYZER. THE ROOT CAUSE FOR THE ERRONEOUS DIFFERENTIALS/FALSE NEGATIVE FLAGS IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MDR REPRESENTS EVEN 8 OF 9 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00829, 00830, 00831, 00832, 00833, 00834, 00836, 00839.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL TEST RESULTS WHEN USING A COULTER LH750 HEMATOLOGY ANALYZER. TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A MANUAL BLOOD SMEAR DIFFERENTIAL THAT CONTAINED BLAST CELLS AND IMMATURE WHITE BLOOD CELLS. THE AUTOMATED DIFFERENTIAL DID NOT HAVE INSTRUMENT GENERATED FLAGS FOR BLAST CELLS. THERE WERE TWO FLAGS PRESENT, ONE FOR IMMATURE WHITE BLOOD CELLS AND ONE TO REVIEW RESULTS FOR NUCLEATED RED BLOOD CELLS. ERRONEOUS TEST RESULTS WERE RELEASED OUTSIDE THE LABORATORY. IT IS UNK IF PT TREATMENT WAS AFFECTED. NO REPORTS OF DEATH OR SERIOUS INJURY AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 7 OF 9 EVENTS REPORTED BY THIS CUSTOMER FOR SAMPLES TESTED OVER SEPARATE DAYS FOR THE THIRD OF THREE ANALYZERS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK