BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2223593 · Received August 25, 2011

    Report

    Report Number
    1061932-2011-01301
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION AND STORAGE INFORMATION WERE REQUESTED BUT NOT PROVIDED. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN BEFORE AND AFTER THE EVENT, AND THE RECOVERY WAS WITHIN THE ASSAY LIMITS. THE LH750 INSTRUMENT SENSITIVITY IS SET TO [2202], WHICH IS MID LEVEL FOR BLAST DIFFERENTIAL PARAMETER. RAW DATA WAS REQUESTED BUT IS NO LONGER AVAILABLE. THE INSTRUMENT WBC COUNT FOR THIS SPECIMEN WAS 1.04. BECAUSE THE OPERATOR HAD THE INSTRUMENT SETUP TO PRINT AND DISPLAY RESULTS TO THE TENTH DECIMAL PLACE (1.0), THE PATIENT WAS ROUNDED TO 1.0 AND THE REFLEX RULE DID NOT PRODUCE FLAGS. BEC FIELD SERVICE ENGINEER (FSE) CHANGED REPORTING UNITS TO AN EXTRA DECIMAL PLACE AND SET REFLEX AT 1.04. THE FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES. THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS, AND SYSTEM VALIDATION WAS DOCUMENTED IN THE CUSTOMERS QC RECORD. THE ROOT CAUSE FOR MISSED BLAST FLAGGING IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT COULTER LH 750 HEMATOLOGY ANALYZER DID NOT FLAG FOR BLAST CELLS. THE INSTRUMENT AUTO VERIFIED THE SAME PATIENT SPECIMEN WITH A WBC OF 1.0. THE CUSTOMER HAS SETUP A DECISION RULE THAT FLAGS SPECIMENS FOR WBC RESULTS OF 1.0 AND LOWER. NO INSTRUMENT FLAG WAS GENERATED. THE PATIENT RESULTS WERE TRANSMITTED AND ERRONEOUS RESULTS WERE REPORTED OUT. THE CUSTOMER PERFORMED A MANUAL DIFFERENTIAL AND A BLAST CELL WAS SEEN ON THE SMEAR. THE PATIENT RESULTS ARE SHOWN IN THE ATTACHED FILE. THERE WAS NO EFFECT TO PATIENT TREATMENT AND NO DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR