BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 500 INSTRUMENT

    MDR report key: 2411821 · Received January 12, 2012

    Report

    Report Number
    1061932-2012-00128
    Event Type
    Malfunction
    Date Received
    January 12, 2012
    Date of Event
    December 12, 2011
    Report Date
    December 12, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN BD EDTA 3.0 ML VACUTAINER TUBES AND SAMPLED WITHIN 1 HOUR OF DRAWING. THE SPECIMENS WERE STORED AT ROOM TEMPERATURE AND PLACED ON MECHANICAL ROCKER PRIOR TO SAMPLING. PER THE CUSTOMER COMPLAINT RECORD, THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). CONTROLS WERE RUN BEFORE THIS INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. CONTROLS WERE RUN AFTER THIS INCIDENT AND 5C NORMAL RECOVERED LOW FOR HGB, MCH AND MCHC. THE CUSTOMER REPLACED THE DILUENT REAGENT, CLEANED THE BLOOD SAMPLE VALVE (BSV), PERFORMED REPRODUCIBILITY AND RAN CONTROLS TO VERIFY INSTRUMENT OPERATION. NO FURTHER ISSUES WERE REPORTED. SERVICE WAS NOT DISPATCHED FOR THIS EVENT SINCE THE CUSTOMER RESOLVED THE ISSUE; HOWEVER A BEC FIELD SERVICE ENGINEER (FSE) CONTINUES TO MONITOR INSTRUMENT OPERATION. PER LABELING: AS APPROPRIATE, THE LH500 SERIES APPLIES INSTRUMENT GENERATED AND/OR LABORATORY-DEFINED FLAGS, CODES, AND/OR MESSAGES TO EACH SET OF PATIENT RESULTS. FLAGS, CODES, AND SUSPECT OR DEFINITIVE MESSAGES ARE USED TO ALERT YOU TO AN INSTRUMENT MALFUNCTION, SPECIMEN ABNORMALITY, ABNORMAL DATA PATTERN, OR ABNORMAL RESULTS. BECKMAN COULTER RECOMMENDS REVIEW, APPROPRIATE TO THE REQUIREMENTS OF THE PATIENT POPULATION, OF ALL RESULTS DISPLAYING A FLAG, CODE OR MESSAGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE COULTER LH 500 INSTRUMENT GENERATED ERRONEOUS COMPLETE BLOOD COUNT (CBC) RESULTS (LOW WBC, HGB, MCH, MCHC AND HIGH RBC, HCT AND PLATELET) FOR THREE (3) PATIENT SPECIMENS WITH AN INSTRUMENT GENERATED FLAG FOR PLATELET PARAMETER ONLY ON THE INITIAL RUN OF THE FIRST PATIENT. THE FIRST PATIENT SPECIMEN WAS RERUN TWICE AND RECOVERED CORRECT RESULTS. THE FIRST PATIENT SPECIMEN WAS SENT TO A REFERENCE LAB SEVERAL DAYS LATER TO CONFIRM THE LH500 RESULTS. THE OTHER TWO (2) PATIENT'S SPECIMENS WERE ALSO RERUN AND RECOVERED CORRECT RESULTS. THE CUSTOMER REPORTED THE RERUN RESULTS. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THE RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHMENT SECTION OF THIS REPORT. THERE WAS NO DEATH, SERIOUS INJURY, OR EFFECT TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 500 INSTRUMENT COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. LH 500 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1