BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2073362 · Received May 1, 2011

    Report

    Report Number
    1061932-2011-00331
    Event Type
    Malfunction
    Date Received
    May 1, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE COLLECTION WAS REPORTED AS USING A VACUTAINER OR MICROTAINER. QC WAS RUN PRIOR TO THE REPORTED EVENT AND WAS WITHIN QC SPECIFICATION WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPLACED THE RED BLOOD COUNT (RBC) DILUENT PUMP ON THE ORIGINAL INSTRUMENT (LH-1) WHICH CORRECTED THE H&H CHECK FAILED PROBLEM. THE FSE ALSO PERFORMED STARTUP, REPRODUCIBILITY IN BOTH MANUAL & AUTO MODES AND MODE TO MODE MATCHING, WHICH WAS VERIFIED. ALL RESULTS WERE WITHIN SPECIFICATIONS. THE ROOT CAUSE FOR THE H&H CHECK FAILED ERROR MESSAGE WAS DUE TO THE HARDWARE THAT WAS REPLACED BY THE FSE DURING INSTRUMENT SERVICING FOR THIS EVENT. PER PRODUCT LABELING, BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER INC. SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON YOUR PATIENT POPULATION. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), ACTION AND CRITICAL LIMITS, DEFINITIVE FLAGS, SUSPECT FLAGS, PARAMETER CODES, DELTA CHECKS, DECISION RULES AND SYSTEM ALARMS. BECKMAN COULTER INC. RECOMMENDS AVOIDING THE USE OF SINGLE MESSAGES OR OUTPUTS TO SUMMARIZE SPECIMEN RESULTS OR PATIENT CONDITIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO ERRONEOUS COMPLETE BLOOD COUNT (CBC) RESULTS WITH H&H CHECK FAILED ERROR MESSAGES, GENERATED BY THE COULTER LH 750 HEMATOLOGY ANALYZER FOR ONE (1) PATIENT. PER THE CUSTOMER'S LAB OPERATING PROCEDURES, SAMPLES WITH H&H CHECK FAILED ERROR MESSAGE ARE RUN ON AN ALTERNATE INSTRUMENT. THE DATA PROVIDED BY THE CUSTOMER SHOWS THE ACCOUNT INITIALLY RAN TWO (2) SAMPLES ON THREE DIFFERENT INSTRUMENTS - THE ORIGINAL INSTRUMENT (LH-1), ALTERNATE INSTRUMENT #1 (LH-2), AND ALTERNATE INSTRUMENT #2 (LH-3). THE LH-1 AND LH-3 INSTRUMENT GAVE H&H CHECK FAILED ERROR MESSAGE; THE LH-2 INSTRUMENT GAVE CELLULAR INTERFERENCE SYSTEM MESSAGE. BASED ON REVIEW OF THE DATA PROVIDED, ERRONEOUSLY HIGH RED BLOOD COUNT (RBC) AND PLATELET (PLT) RESULTS WERE GENERATED BY LH-1. THE RESULTS GENERATED FROM LH-2 ARE CONSIDERED THE CORRECT RESULTS. THE ERRONEOUS RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THERE WAS NO CHANGE TO PATIENT TREATMENT NOR DEATH OR INJURY ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1