BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3051652 · Received April 10, 2013

    Report

    Report Number
    1061932-2013-00612
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: FLOW CELL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING HIGH CONDUCTIVITY READINGS AT 29.6 FOR THE LATEX CONTROL INVOLVING A COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT CONDUCTIVITY HAVE BEEN ADJUSTED MULTIPLE TIMES WITHIN THE LAST FEW WEEKS. THERE WAS NO IMPACT TO PATIENT RESULTS AS A RESULT OF THIS ISSUE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND ATTEMPTED TO ALIGN THE FLOW CELL BUT WAS UNABLE TO OBTAIN ACCEPTABLE LATEX CONTROL RESULTS. THE FSE INSTALLED A NEW FLOW CELL AND ALIGNED IT PROPERLY TO OBTAIN LATEX CONTROL RESULTS WHICH WERE WITHIN SPECIFICATIONS. FAILURE MODE IS ATTRIBUTED TO THE FLOW CELL AND LATRON CONTROL WAS OUT HIGH TO ALERT THE OPERATOR TO AN INSTRUMENT PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152231 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1