BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3336904 · Received September 9, 2013

    Report

    Report Number
    1061932-2013-01962
    Event Type
    Malfunction
    Date Received
    September 9, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 18, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE REPLACED THE DIFFERENTIAL SAMPLE LINE TUBING TO THE DIFFERENTIAL SHEAR VALVE AND TO THE FLOW CELL WHICH RESOLVED THE LEAK AND THE DIFFERENTIAL VOTE OUTS. IN ADDITION, THE FSE ALSO INDICATED THAT THE ANALYZER HAD BEEN SERVICED BY A THIRD PARTY COMPANY AND THAT THE TUBING THROUGH THE VALVES VL50A, VL46B, VL111, VL13, VL25, VL16, VL64, VL59, VL9A AND VL9B WERE IMPROPERLY CUT TOO LONG AND HAD TO BE CUT TO APPROPRIATE LENGTH ACCORDING TO THE LH750 PRODUCT SCHEMATIC, WHICH RESOLVED THE PARTIAL ASPIRATION ERRORS RECOVERED BY THE INSTRUMENT. PER LABELING, BECKMAN COULTER URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT NO DIFFERENTIAL RESULTS (VOTE OUTS) AND PARTIAL ASPIRATION ERRORS GENERATED ON THE COULTER LH 750 HEMATOLOGY ANALYZER. DURING THE ONSITE SERVICE VISIT, A BEC FIELD SERVICE ENGINEER (FSE) DISCOVERED A CONTAINED DILUENT LEAK AT THE SAMPLE LINE TUBING TO THE DIFFERENTIAL SHEAR VALVES. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT AND THE AMOUNT REPORTED WAS OF APPROXIMATELY ONE DROP OF DILUENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF LABORATORY COAT, GLOVES, AND PROTECTIVE EYEWEAR AT THE TIME OF OCCURRENCE. THERE WAS NO BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. MEDICAL ATTENTION WAS NOT SOUGHT. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450826 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 750 NA

    Patients

    Seq Age Sex Outcome Treatment
    1