BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3062242 · Received April 16, 2013

    Report

    Report Number
    1061932-2013-00600
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO MEDWATCH #1061932-2013-00601 FOR AN ASSOCIATED REPORT RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING LOWER NE% (NEUTROPHILS), LY% (LYMPHOCYTES) AND HIGHER EO% RESULTS WITHOUT INSTRUMENT GENERATED MESSAGE WHEN COMPARED TO THE MANUAL DIFFERENTIAL RESULTS INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER, SERIAL NUMBER (B)(4). THE SAMPLE WAS REPEATED ON AN ALTERNATE LH 780 ANALYZER (SERIAL NUMBER (B)(4)) AND LOWER NE% (NEUTROPHILS), LY% (LYMPHOCYTES) AND HIGHER EO% RESULTS WITHOUT INSTRUMENT GENERATED MESSAGE WERE AGAIN OBTAINED WHEN COMPARED TO THE MANUAL DIFFERENTIAL RESULTS. THIS REPORT REFERENCES THE ORIGINAL COULTER LH 780 HEMATOLOGY ANALYZER SERIAL NUMBER (B)(4). PLEASE REFER TO MEDWATCH #1061932-2013-00601 FOR THE REPORT ON THE ALTERNATE ANALYZER (SERIAL NUMBER (B)(4)). QUALITY CONTROL RESULTS BEFORE AND AFTER THE EVENT RECOVERED WITHIN SPECIFICATIONS. THE CUSTOMER STATED THAT THE SAMPLE ARRIVED REFRIGERATED AND STORED IN THE REFRIGERATOR SINCE IT WAS RECEIVED BY THE LABORATORY. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND MADE A SLIGHT ADJUSTMENT TO THE LASER ALIGNMENT TO REDUCE THE SCATTER COEFFICIENT OF VARIATION (%CV) AND INCREASE THE SCATTER MEANS. THE FSE EXPLAINED THAT THIS WAS THE ONLY MINOR ISSUE NOTICED PERTAINING TO AN ERRONEOUS EO% READING AND DOCUMENTED THAT THIS WOULD NOT HAVE CAUSED THE DRAMATIC DIFFERENCE IN THE EO% READINGS BETWEEN THE AUTOMATED AND MANUAL DIFFERENTIAL RESULTS. THE CUSTOMER INDICATED THAT THE SAMPLE WAS PROCESSED ABOUT 24 HOURS AFTER SAMPLE COLLECTION AND THE TIME DELAY COULD HAVE BEEN THE ROOT CAUSE. THERE WERE NO OBVIOUS ISSUES WITH THE DIFFERENTIAL PROCESSING SIDE OF THE INSTRUMENT AND THE RESULTS COMPARISON BETWEEN THE TWO INSTRUMENTS (ORIGINAL AND ALTERNATE) MATCHED ALMOST EXACTLY AFTER RUNNING THE SAMPLE (B)(6) PATIENT ON EACH ANALYZER. FAILURE MODE IS UNKNOWN AND RESULTS FROM BOTH THE ORIGINAL AND ALTERNATE ANALYZERS DID NOT PROVIDE ANY INSTRUMENT GENERATED MESSAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162907 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1