BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3803299 · Received May 9, 2014

    Report

    Report Number
    1061932-2014-01040
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 11, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE SERVICE HISTORY FOR THIS DEVICE IDENTIFIED THE ISSUE HAD BEEN ONGOING. THE FIRST SERVICE CALL BY A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) OCCURRED ON (B)(4) 2014. THERE WERE A TOTAL OF 7 SERVICE CALLS ASSOCIATED WITH THIS EVENT. TROUBLESHOOTING INCLUDED: CLEANING, ZAPPING THE WBC (WHITE BLOOD CELL) BATH/APERTURES, REPLACING THE CHECK VALVE IN THE MIXING BUBBLE PATHWAY AND WBC O-RINGS, AND RESEATING SOLENOID 19. ON (B)(4) 2014, THE FSE IDENTIFIED THE WBC VENT LINE WAS KINKED UNDER A CABLE TIE; THE FSE REPLACED AND REROUTED THE TUBING. ON (B)(4) 2014, THE FSE IDENTIFIED THE WBC BATH VENT WAS CLOGGED, NOT ALLOWING MIXING BUBBLES TO ENTER THE WBC BATH; THE FSE REMOVED THE CLOG. THESE ACTIONS RESOLVED THE ISSUE. FAILURE MODE: CAN BE ATTRIBUTED TO KINKED TUBING AND A CLOGGED WBC BATH VENT. THERE ARE SEVEN MDRS FOR EVENTS REPORTED ON SEVEN DIFFERENT DATES: 1061932-2014-01037, 1061932-2014-01038, 1061932-2014-01039, 1061932-2014-01040, 1061932-2014-01041, 1061932-2014-01042, 1061932-2014-01043.

    Description of Event or Problem · 1

    ON (B)(4) 2014, THE CUSTOMER REPORTED NO MIXING BUBBLES IN THE WBC (WHITE BLOOD CELL) BATH AND AN ERROR CONDITION OF VOTE-OUT (NON-NUMERICAL RESULTS) FOR SOME PATIENT SAMPLES WHEN USING THE COULTER® LH 750 HEMATOLOGY ANALYZER. THE VOTE-OUT OCCURRED WITH THE WBC PARAMETER AND THE ABSOLUTE VALUES FOR DIFFERENTIAL RESULTS. THERE WERE NO REPORTS OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT. NOTE: THIS EVENT WAS REPORTED ON SEVEN SEPARATE DATES. THIS MDR IS FOR THE EVENT OCCURRING ON (B)(4) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280506 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1