BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2353457 · Received November 30, 2011

    Report

    Report Number
    1061932-2011-02388
    Event Type
    Injury
    Date Received
    November 30, 2011
    Date of Event
    January 29, 2011
    Report Date
    January 30, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE FOR THIS EVENT. BECKMAN COULTER INC. ASSESSMENT OF CUSTOMER SUPPLIED RAW DATA INDICATED THAT THE ROOT CAUSE OF THE EVENT WAS THAT THE INSTRUMENT ALGORITHM CLASSIFIED THE NEUTROPHILS AS BASOPHILS DUE TO THE ABNORMAL SAMPLE PATTERN. THE ROOT CAUSE OF THE REPORTING OF THE ERRONEOUS RESULTS WAS USE ERROR. THERE WERE INSTRUMENT GENERATED FLAGS TO ALERT THE OPERATOR TO REVIEW THE RESULTS. AS PART OF A RETROSPECTIVE REVIEW, THIS EVENT WAS DETERMINED TO BE REPORTABLE. MDRS ASSOCIATED WITH THIS EVENT: 1061932-2011-02388; 1061932-2011-02389. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A COULTER LH 750 HEMATOLOGY ANALYZER AND A COULTER LH 500 HEMATOLOGY ANALYZER GENERATED ERRONEOUS ELEVATED BASOPHILS (BA%) AND ERRONEOUSLY LOW ABSOLUTE NEUTROPHIL (NE#) RESULTS WITH INSTRUMENT GENERATED FLAGS FOR ONE PATIENT'S SAMPLES OVER TWO DAYS. THIS IS REPORT ONE OF TWO AND REPRESENTS THE ERRONEOUSLY ELEVATED BA% RESULT WHICH WAS GENERATED ON A COULTER LH 750 HEMATOLOGY ANALYZER ON (B)(6) 2011. THE ELEVATED BA% CAUSED THE ABSOLUTE NEUTROPHILS (NE#) RESULT TO CALCULATE ERRONEOUSLY HIGH. DIFFERENTIAL RESULTS WERE ACCOMPANIED BY INSTRUMENT GENERATED FLAGS WHICH, PER BECKMAN COULTER INC. LABELING, NECESSITATED THE REVIEW OF RESULTS. THE ERRONEOUS NE# RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WHILE IT IS UNKNOWN AS TO WHETHER THE ERRONEOUS DIFFERENTIAL RESULT WAS THE CAUSE FOR PATIENT HOSPITALIZATION, IT WILL BE ASSUMED TO BE THE CASE FOR THE PURPOSES OF THIS REPORT. SUBSEQUENTLY, A MANUAL DIFFERENTIAL WAS PERFORMED. THE RESULTS INDICATED A SIGNIFICANTLY LOWER BASOPHIL AND HIGHER NEUTROPHIL RESULT. THE MANUAL SMEAR RESULTS WERE REGARDED AS VALID. CONTROLS WERE EXECUTED BEFORE THE INCIDENT AND WERE WITHIN THE EXPECTED RANGE. NO SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization