BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 2021273 · Received March 17, 2011

    Report

    Report Number
    1061932-2011-00148
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    February 11, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN 5 ML VENOJECT VACUTAINER TUBES AND TRANSPORTED REFRIGERATED AND STORED AT ROOM TEMPERATURE. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND THE ERROR WAS DISCOVERED BECAUSE THE BATCH CONTROL RECOVERED OUTSIDE QC LIMITS. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND REPLACED THE LS PRE-AMP ASSEMBLY AND ADJUSTED THE GAIN, WHICH WAS THE ROOT CAUSE OF THIS EVENT. THE FSE ALSO VERIFIED THE INSTRUMENTS OPERATION. 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. THERE MAY BE SITUATIONS WHERE THE PRESENCE OF RARE EVENTS MAY FAIL TO TRIGGER A SUSPECT MESSAGE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 750 ANALYZER GENERATED ERRATIC DIFFERENTIAL RESULTS ON TWENTY-SIX (26) PATIENT SPECIMENS. OF TWENTY-SIX (26) SPECIMENS TWELVE (12) HAD INSTRUMENT GENERATED R (REVIEW RESULT) FLAGS ON THE DIFFERENTIAL PARAMETERS. THE CUSTOMER STATED THAT THE LABORATORY PROTOCOL IS TO RUN THE SPECIMENS IN BATCHES OF FIFTY (50) SPECIMENS, PRECEDED AND FOLLOWED BY A CONTROL. THE OPERATOR NOTICED THAT THE CONTROL RECOVERED OUTSIDE QC LIMITS AND ABORTED THE BATCH RUN AFTER TWENTY SIX (26) SPECIMENS HAD BEEN COMPLETED. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOM RERAN THE SPECIMENS ON AN ALTERNATE INSTRUMENT AND VERIFIED THE RESULTS BEFORE REPORTING. 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 750 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1