BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 ANALYZER

    MDR report key: 3112540 · Received May 14, 2013

    Report

    Report Number
    1061932-2013-00823
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2019
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) DATA SUBMITTED FOR BOTH INSTRUMENTS WAS WITHIN SPECIFICATIONS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CLEANED THE BLOOD SAMPLING VALVE (BSV) AND RETIC SHEAR VALVE. THE FSE ALSO PERFORMED TWO (2) SUCCESSFUL REPRODUCIBILITY TESTS AND DID NOT IDENTIFY AN INSTRUMENT MALFUNCTION. FAILURE MODE FOR THE DISCREPANT HGB RESULTS COULD NOT BE DETERMINED AS THE FSE DID NOT IDENTIFY AN INSTRUMENT MALFUNCTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER THAT TWO PATIENT SAMPLES RECOVERED ERRONEOUS HIGH HEMOGLOBIN (HGB) RESULTS ON THE COULTER LH 750 ANALYZER WITHOUT INSTRUMENT GENERATED FLAGS/MESSAGES COMPARED TO RERUN RESULTS ON THIS INSTRUMENT AND ON A DIFFERENT INSTRUMENT WHICH THE CUSTOMER CONSIDERED CORRECT. PER THE CUSTOMER, THE HIGHER HGB RESULTS WERE GENERATED AFTER THE INSTRUMENT WAS IN SHUTDOWN. DATA SUBMITTED FOR REVIEW INDICATED THAT BOTH PATIENT SAMPLE RESULTS WERE GENERATED WITH AN OPERATOR DEFINABLE ERROR MESSAGES "HEMATOCRIT/HEMOGLOBIN (H&H) CHECK FAILED", PROMPTING THE CUSTOMER TO REPEAT TEST ON AN ALTERNATE INSTRUMENT. THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LABORATORY AS THE OPERATOR INDICATED THAT THE RESULTS WERE NOT ACCEPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212500 COULTER® LH 750 ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR