BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 755 ANALYZER

    MDR report key: 2021274 · Received March 17, 2011

    Report

    Report Number
    1061932-2011-00149
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011324
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. ACCORDING TO THE RAW DATA ANALYSIS, THE PATTERN DOES NOT DETECT ANY ABNORMAL DATA PATTERN AS IR IS NOT SEEN AS POSSESSING ANY INTERFERENCE THAT WOULD BE SUSPECTED TO AFFECT THE RETICULOCYTES PERCENTAGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE RETIC PAK LEVEL. 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. THE LH 700 SERIES APPLIES INSTRUMENT-GENERATED AND/OR LABORATORY-DEFINED FLAGS, CODES, AND/OR MESSAGES TO EACH SET OF PATIENT RESULTS. FLAGS, CODES, SUSPECT AND 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 YOUR PATIENT POPULATION, OF ALL RESULTS DISPLAYING A FLAG, CODE OR OTHER MESSAGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 755 ANALYZER GAVE ERRONEOUSLY HIGH RETIC RESULTS ON A SPECIFIC SPECIMEN WITHOUT INSTRUMENT GENERATED RETIC FLAG, BUT GAVE A NUCLEATED RED BLOOD COUNT (NRBC) INSTRUMENT GENERATED MESSAGE FOR THE DIFFERENTIAL. THE RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, A MANUAL RETIC COUNT RECOVERED LOWER. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 755 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 755 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1