BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 ANALYZER

    MDR report key: 3173786 · Received June 17, 2013

    Report

    Report Number
    1061932-2013-01171
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE VERIFIED THE INSTRUMENT OPERATION AND FOUND NO ISSUES. RAW DATA WAS REQUESTED FROM THE CUSTOMER FOR THIS EVENT. HOWEVER, PER EMAIL FROM THE FSE, DATA HAS BEEN PURGED FROM THE INSTRUMENT. FAILURE MODE OF THE ERRONEOUS RESULTS OBTAINED ON THE LH780 ANALYZER CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT ERRONEOUS NUCLEATED RED BLOOD CELLS (NRBC) RESULTS WERE OBTAINED FOR A PATIENT SAMPLE ANALYZED ON THE COULTER LH 780 ANALYZER. THERE WERE NO INSTRUMENT GENERATED MESSAGES IN RELATION TO THIS EVENT. THE CUSTOMER INDICATED THAT CONTROLS PRIOR TO THE EVENT RECOVERED WITHIN SPECIFICATION. THE OPERATOR WAS PROMPTED TO REVIEW THE SLIDES DUE TO LABORATORY CRITERIA SET UP IN THE LH780 INSTRUMENT. THE MANUAL SLIDE REVIEW REVEALED AN NRBC% OF 11.0. BASED ON PROVIDED DATA, THE LH780 GENERATED AN ERRONEOUS HIGH NEUTROPHILS (NE%), ERRONEOUS LOW LYMPHOCYTES (LY%) AS WELL AS AN ERRONEOUS LOW NRBC% COUNT COMPARED TO THE MANUAL DIFFERENTIAL COUNT THAT WERE CONSIDERED CORRECT BY THE CUSTOMER. ALL THE OTHER DIFFERENTIAL PARAMETERS OBTAINED FROM THE LH780 ANALYZER CORRELATED TO THE MANUAL SLIDE REVIEW. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO DEATH, INJURY OR EFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THE NRBC RESULT OBTAINED FROM THE MANUAL SLIDE REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273383 COULTER® LH 780 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR