BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2970587 · Received February 20, 2013

    Report

    Report Number
    1061932-2013-00248
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FAILURE MODE WAS DETERMINED TO BE AN ADJUSTMENT NEEDED FOR THE LATRON SCATTER AND LS CONNECTOR WHICH HAD TO BE RESEATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED INTERMITTENT ISSUES WITH HIGH BASOPHILS INVOLVING THE COULTER LH 780 HEMATOLOGY ANALYZER. THE CUSTOMER PROVIDED SIX PATIENT DATA WHICH WERE CONSIDERED INCORRECT FOR HIGH BASOPHILS WHICH WERE GENERATED OVER A PERIOD OF THREE DAYS. DATA REVIEW INDICATED FIVE SAMPLES GENERATED ERRONEOUSLY HIGH BASOPHIL PERCENTAGE (BA%) AND ABSOLUTE BASOPHILS NUMBER (BA#) WITHOUT INSTRUMENT GENERATED FLAGS, WHEN COMPARED TO THE RERUN ON THE ORIGINAL ANALYZER OR AN ALTERNATE LH780 ANALYZER. THIS REPORT IS FOR THE EVENT WHICH OCCURRED ON (B)(6) 2013. PLEASE SEE MEDWATCH #1061932-2013-00246 AND #1061932-2013-00247 FOR THE REPORTS OF THE EVENTS WHICH OCCURRED ON (B)(6) 2013 RESPECTIVELY. THE CUSTOMER REPORTED THAT ERRONEOUS BASOPHILS WERE GENERATED FOR ONE PATIENT ON (B)(6) 2013. THE SAMPLE WAS REPEATED ON AN ALTERNATE LH 780 ANALYZER AND RESULTS WHICH WERE CONSIDERED CORRECT WERE OBTAINED. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND THERE WAS NO AFFECT OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) NOTICED THAT THE SCATTER WAS RUNNING LOW ON LATRON AND PROCEEDED TO ADJUST THE SCATTER FOR LATRON. THE FSE RAN (B)(4) SAMPLES WITH NO HIGH BASOPHIL COUNTS OBTAINED. THE FSE INDICATED THAT THE CUSTOMER WAS STILL REPORTING HIGH BASOPHIL COUNTS AS WELL AS DIFF AND RETIC R CODES AND DISCOVERED THE THREE ELEMENT LS (LIGHT SCATTER) SENSOR CONNECTOR AT THE LS PREAMP TO BE THE SOURCE OF THE NOISE. THE FSE RESEATED THE CONNECTOR AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74599 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1