BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2169807 · Received July 15, 2011

    Report

    Report Number
    1061932-2011-00882
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    November 19, 2009
    Report Date
    November 20, 2009
    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

    THIS SAMPLE WAS BEING TESTED DURING THE POST-INSTALLATION STUDY OF SOFTWARE VERSION 2D1. THE INSTRUMENT WAS WITHIN QUALITY CONTROL SPECS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). THE SENSITIVITY FOR FLAGGING WAS SET AT [3201], WHICH IS HIGH-LEVEL FOR BLASTS, MID-LEVEL FOR VARIANT LYMPHOCYTES AND SET TOO OFF FOR IMM. NE 1 AND LOW LEVEL FOR IMM. NE 2 FLAGGING. 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. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. RAW DATA ANALYSIS DETERMINED THAT THE DATA FEATURES FROM THE SAMPLE WERE ON THE BOUNDARY CONDITION OF THE BLAST FLAGGING RULE AND DID GENERATE IMM NE2 FLAG. THE ROOT CAUSE FOR THE LACK OF FLAG FOR BLAST CELLS FOR THIS PARTICULAR PT WAS ATTRIBUTED TO THE SPECIMEN. THE SPECIMEN WAS NOT SIGNIFICANTLY ABNORMAL TO TRIGGER BLAST FLAGGING. HOWEVER, THE ANALYZER DID GENERATE AN IMM. NE 2 DIFFERENTIAL FLAG THAT ALERTS THE OPERATOR TO FURTHER REVIEW THE PT SAMPLE. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4), 2008 AND (B)(4), 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ERRONEOUS DIFFERENTIAL RESULTS WERE OBTAINED FOR ONE PT SAMPLE WHEN USING A COULTER LH 750 HEMATOLOGY ANALYZER. THE TEST RESULTS WERE DETERMINED TO BE ERRONEOUS WHEN COMPARED TO A MANUAL BLOOD SMEAR DIFFERENTIAL WITH BLAST CELLS. THERE WERE NO INSTRUMENT GENERATED FLAGS FOR THE PRESENCE OF BLAST CELLS. THERE WAS AN INSTRUMENT GENERATED IMM NE 2 DIFFERENTIAL FLAG. IMM NE 2 IS A FLAG FOR SUSPECT IMMATURE NEUTROPHILS, PRIMARILY METAMYELOCYTES, MYELOCYTES, AND PROMYELOCYTES. ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. NO REPORTS OF DEATH OR SERIOUS INJURY AND NO EFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK