BEUDAMED
    FDA Adverse Event Summary report: N

    COULTER® LH 780

    MDR report key: 2120920 · Received June 13, 2011

    Report

    Report Number
    1061932-2011-00627
    Date Received
    June 13, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 10, 2011
    Manufacturer
    BECKMAN COULTER INC
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION INFORMATION WAS NOT PROVIDED FOR THIS EVENT. CONTROLS WERE RUN BEFORE AND AFTER THE REPORTED EVENT AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATION. ON (B)(6) 2011, A BCI FIELD SERVICE ENGINEER (FSE) FSE FOUND A BROKEN SPRING ON THE 5-DIFF LYSE PUMP PM4 AND REPLACED THE PUMP. FSE VERIFIED THE LOW / HIGH ELYSE VOLUMES WERE VERIFIED. STARTUP & QC WERE TESTED AND WERE WITHIN SPECIFICATIONS. SEVERAL SAMPLES WERE RERUN ON BOTH LH1 & LH2 AND RESULTS CORRELATED. REPAIR WAS VERIFIED AND SYSTEM WAS VALIDATED. THE ROOT CAUSE FOR THE ERRONEOUS DIFF RESULTS CAN BE ATTRIBUTED TO THE HARDWARE REPLACED BY SUBSEQUENT INSTRUMENT SERVICE BY THE FSE.

    Description of Event or Problem · 1

    CUSTOMERS CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS DIFF RESULTS (LOW LY AND HIGH BA) ON FOUR PATIENT SAMPLES WITHOUT INSTRUMENT GENERATED FLAGS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. REVIEW OF THE SAMPLE PRINTOUTS PROVIDED SHOW MANUAL DIFFS WERE ONLY PERFORMED ON PATIENT'S 1 & 2 WHICH REVEALED HIGHER LY AND LOWER BA RESULTS WHEN COMPARED TO INSTRUMENT RESULTS. PATIENT'S 3 & 4 WERE RERUN ON THE SAME INSTRUMENT (LH2); RERUN RESULTS GENERATED HIGHER LY AND LOWER BA. PATIENT RESULTS ARE PROVIDED. NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC LH 780 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1