BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3894353 · Received June 25, 2014

    Report

    Report Number
    1061932-2014-01453
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND DID NOT OBSERVE A LEAK OR ERROR AND WAS UNABLE TO REPLICATE THE LEAK AFTER STARTUP. THE FSE IDENTIFIED THAT THE INSTRUMENT WAS GENERATING AN ERROR CONDITION OF VOTEOUTS (NON-NUMERIC RESULTS) FOR THE DIFFERENTIAL PARAMETERS. THE FSE DETERMINED THE DIFF (DIFFERENTIAL) MIXING MOTOR WAS NOT MIXING PROPERLY BECAUSE A CABLE WAS LOOSE. THE FSE RECONNECTED THE DIFF MIXING MOTOR AND THE INSTRUMENT RAN WITHOUT VOTEOUTS ON THE DIFFERENTIAL PARAMETERS. THE INSTRUMENT WAS RUNNING WITHOUT LEAKS OR ERRORS FOLLOWING THE SERVICE. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED A LEAK WHEN USING THE COULTER LH 780 HEMATOLOGY ANALYZER. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THE FSE COULD NOT CONFIRM THE LEAK. THE FSE DID OBSERVE THE INSTRUMENT GENERATED AN ERROR CONDITION OF VOTEOUTS (NON-NUMERIC RESULTS) FOR THE DIFFERENTIAL PARAMETERS. THE FSE DETERMINED THE CAUSE OF THE VOTEOUTS TO BE A LOOSE CABLE ON THE DIFFERENTIAL MIXING MOTOR. THE OPERATOR WAS WEARING A LAB COAT AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370669 COULTER LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1