BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® LH 500 HEMATOLOGY ANALYZER

    MDR report key: 2190012 · Received August 3, 2011

    Report

    Report Number
    1061932-2011-01026
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE), ADJUSTED THE REGULATOR FROM 53 TO 60, ADJUSTED THE DIFF LIGHT SCATTER FROM 81 TO 90 AND THE HGB LAMP VOLTAGE. INSTRUMENT PERFORMANCE WAS VERIFIED AFTER THE REPAIR AND THE RESULTING % COEFFICIENT OF VARIATION WAS WITHIN EXPECTED RANGES. ROOT CAUSE IS UNKNOWN BASED ON THE AVAILABLE INFORMATION, HOWEVER USER ERROR CONTRIBUTED TO THE EVENT AS THE USER DISREGARDED AN ANALYZER GENERATED R FLAG, ALERTING THE OPERATOR TO REVIEW THE RESULTS, AND RELEASED THE ERRONEOUS RESULT FROM THE LABORATORY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011, AN ERRONEOUSLY LOW PLATELET RESULT WITH AN INSTRUMENT GENERATED R FLAG WAS GENERATED FROM A COULTER LH 500 HEMATOLOGY ANALYZER FOR ONE CANCER PATIENT SAMPLE. THE R FLAG ASSOCIATED WITH THE ERRONEOUS RESULTS INSTRUCTS THE USER TO REVIEW THE RESULT ACCORDING TO THE LABORATORY'S PROTOCOL. THE USER DID NOT HEED THE INSTRUMENT FLAG AND RELEASED THE ERRONEOUS TEST RESULT OUT OF THE LABORATORY. THE PATIENT WAS SENT TO THE HOSPITAL TO UNDERGO TREATMENT AS A RESULT OF THE ERRONEOUS RESULT. AT THE HOSPITAL, BEFORE ADMINISTERING TREATMENT, THE PATIENT WAS REDRAWN (SAMPLE TWO) AND THE REPEAT PLATELET SAMPLE WAS RUN ON ANOTHER ANALYZER WHICH GENERATED A HIGHER RESULT THAT WAS DEEMED TO BE VALID. THIS RESULT WAS REPORTED OUT OF THE LABORATORY AND THE PATIENT TREATMENT WAS CANCELED. THE PATIENT WAS REDRAWN THE NEXT DAY (SAMPLE 3). THE THIRD SAMPLE WAS RETESTED ON ANOTHER INSTRUMENT AND GENERATED A RESULT CONSISTENT WITH SAMPLE TWO. THE UNIT WAS PERFORMING WITHIN QUALITY CONTROL SPECIFICATIONS DURING THE TIMEFRAME OF THE EVENT. SAMPLE COLLECTION/HANDLING INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE CUSTOMER COMMUNICATED THAT THIS ISSUE HAS OCCURRED PREVIOUSLY HOWEVER COULD NOT PROVIDE DETAILS ON ANY PREVIOUS EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization