BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER GENS HEMATOLOGY ANALYZER

    MDR report key: 2223190 · Received August 12, 2011

    Report

    Report Number
    1061932-2011-01168
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    October 30, 2009
    Report Date
    October 30, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKL
    PMA / PMN Number
    K962988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED FOR THE PERIOD BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR IS FOR ANALYZER 2 OF 2. SEE MDR# 1061932-2011-01167 FOR ANALYZER 1 OF 2. THE SAMPLE WAS COLLECTED IN A 4 ML VACUTAINER TUBE. RAW DATA WERE REQUESTED FOR ANALYSIS BUT NOT PROVIDED BY THE CUSTOMER. SERVICE INFO WAS NOT PROVIDED. THE ROOT CAUSE IS UNK; HOWEVER, PER BECKMAN COULTER INC LABELING, ERYTHROCYTE INCLUSIONS STAINED BY NEW METHYLENE BLUE, IF SUFFICIENTLY NUMEROUS WITHIN A SAMPLE, AND SOME HEMOGLOBINOPATHIES (SUCH AS SICKLE CELL ANEMIA) MIGHT AFFECT THE ACCURACY OF THE RETICULOCYTE ENUMERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE GENS HEMATOLOGY ANALYZER GENERATED AN ERRONEOUSLY HIGH RETICULOCYTE COUNT (17.0%) ON A SAMPLE FROM ONE PT. IT IS UNK IF THE TEST RESULTS WERE ACCOMPANIED BY INSTRUMENT-GENERATED MESSAGES. ERRONEOUS TEST RESULTS WERE REPORTED OUTSIDE OF THE LAB. A MANUAL RETICULOCYTE COUNT WAS SUBSEQUENTLY PERFORMED WITH A RESULT OF 4.3%. THE CUSTOMER BELIEVED THE MANUAL COUNT TO BE CORRECT AND A CORRECTED REPORT WAS ISSUED. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK