BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 2242367 · Received September 10, 2011

    Report

    Report Number
    1061932-2011-01392
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A BD EDTA VACUTAINER TUBE AND SAMPLED WITHIN 1 HOUR AND 10 MINUTES. CONTROLS WERE RUN BEFORE AND AFTER THE EVENT. QC WAS PERFORMING WITHIN THE SPECIFICATIONS. FLAGGING SENSITIVITY PREFERENCES WERE SET AT [3222], WHERE BLAST IS SET AT HIGH, IMM NE2, VARIANT LYMPH AND IMM NE1 ARE SET AT MID ON ALL LH780 INSTRUMENTS. ANALYSIS OF RAW DATA FROM THE INSTRUMENTS PROVIDED THE FOLLOWING: A SUSPECT FLAG IS SET BY THE ALGORITHM IF THE SAMPLE SHOWS DOMINANT AND ELONGATED POPULATIONS. THE RUNS MISSING FLAGS EACH SHOW A SINGLE DOMINANT POPULATION, BUT NEITHER OF THEM WAS SIGNIFICANTLY ELONGATED. THE ABNORMALITIES OF THE HISTOGRAM PATTERNS ARE ON THE BORDERLINE OF THE FLAGGING CONDITIONS. PROBLEM OCCURRED ONLY ON THIS SINGLE PATIENT SAMPLE, AND IS NOT REPRODUCIBLE. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE ROOT CAUSE FOR THE INSTRUMENT NOT FLAGGING THE SPECIMEN FOR BLASTS CELLS IS THAT THE ABNORMAL SPECIMEN WAS ON THE BORDERLINE CONDITION OF THE ALGORITHM CRITERIA FOR BLAST FLAGGING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT COULTER LH 780 HEMATOLOGY ANALYZER FAILED TO PROVIDE A BLAST FLAG FOR ONE PATIENT SPECIMEN. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY, AND QUESTIONED BY THE PHYSICIAN AS THE RESULTS WERE NOT FITTING INTO THE PATIENT'S PREVIOUS HISTORY. REPEAT TESTING WAS PERFORMED ON THE SAME AND THREE (3) DIFFERENT INSTRUMENTS. ONE INSTRUMENT PRODUCED BLAST FLAG, TWO INSTRUMENTS PRODUCED NO FLAG, AND THE LAST INSTRUMENT DID NOT PRODUCE DIFFERENTIAL RESULTS. MANUAL DIFFERENTIAL SHOWED 77% BLAST. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT AS A RESULT OF THIS INCIDENT. THE EVENT ON THE 2ND INSTRUMENT THAT FAILED TO PROVIDE BLAST FLAG IS REPORTED IN MDR# 1061932-2011-01393.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR