BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2851879 · Received November 29, 2012

    Report

    Report Number
    1061932-2012-02790
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIFIC PATIENT SAMPLE WAS COLLECTED USING A BUTTERFLY COLLECTION DEVICE INTO A 3ML HEMOGUARD TUBE AND STORED LESS THAN 12 HOURS AT ROOM TEMPERATURE. THE CONTROLS WERE NOT RUN BEFORE AND AFTER THE INCIDENT. HOWEVER, THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. A PRECISION REPORT INCLUDED WITH THE PATIENT DATA SHOWS GOOD PRECISION (LOW CV%) ON ALL PARAMETERS. A BEC FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND VERIFIED THE PERFORMANCE OF THE INSTRUMENT. THE FSE FOUND NO INSTRUMENT PROBLEMS AND COULD NOT REPLICATE THE REPORTED ISSUE. UPON REVIEW OF THE RAW DATA ANALYSIS, SHOWED NO INDICATION OF A ALGORITHMIC OR HARDWARE MALFUNCTION. THE CAUSE OF THE DIFFERENCE OF THE PATIENT RESULTS COULD NOT BE DETERMINED. ROOT CAUSE IS UNKNOWN. PER PRODUCT LABELING: BECKMAN COULTER DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN SAMPLES AND SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF THE INSTRUMENT RESULTS. ALL FLAGGING OPTIONS INCLUDE REFERENCE RANGES (H/L), CODES, AND FLAGS. BECKMAN COULTER 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. (BEC) TO REPORT THAT THE COULTER LH 750 HEMATOLOGY ANALYZER GENERATED ERRONEOUS LOW WHITE BLOOD COUNT (WBC) AND HIGH RED BLOOD COUNT (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), PLATELET (PLT), AND LYMPHOCYTES (LY%), AND MONOCYTES (MO%) RESULTS ON ONE (1) PATIENT SAMPLE RUN IN PRIMARY MODE WHICH WAS NOT FLAGGED FOR NEUTROPHIL BANDS. REVIEW OF THE INITIAL RUN DID NOT SHOW ANY INSTRUMENT FLAGS WERE GENERATED. THE INITIAL RUN RESULTS WERE REVIEWED AND THE RELEASE WAS CANCELLED. THE SAME SAMPLE WAS RERUN IN BOTH SECONDARY AND PRIMARY MODE MORE THAN 12 HOURS LATER WITH INSTRUMENT GENERATED FLAGS (IMM. NE1 AND IMM. NE2) WHICH WERE CONSIDERED CORRECT. THE CUSTOMER INDICATED THAT THEIR FLAGGING PREFERENCES ARE SET TO '2233' (MID-LEVEL FOR BLAST, VARIANT LYMPH, HIGH-LEVEL FOR IMM NE 1, AND IMM NE 2). A MANUAL DIFFERENTIAL WAS ALSO PERFORMED BUT WAS NOT PROVIDED. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, THERE WAS NO AFFECT TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT AS THE INITIAL RESULTS WERE CANCELLED AND THE RESULTS WERE AMENDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1