BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 3232813 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01416
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 24, 2013
    Report Date
    June 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE INSPECTED THE INSTRUMENT AND FOUND HEMOGLOBIN (HGB) RUNNING LOW AND OUT ON QC. THE FSE DETERMINED THAT HGB OUTPUT IS TOO LOW (WOULD NOT GO ABOVE 0.38 AND THE NORMAL VALUE IS 0.60). THE FSE REPLACED THE HGB PREAMPLIFIER, RESOLVING THE ISSUES. AS PART OF PREVENTATIVE MAINTENANCE, THE FSE ALSO INSTALLED MULTI-TRANSDUCER MODULE (MTM) OPTICAL COVERS AND REPLACED THE HGB LAMP. UPON FURTHER INSPECTION, THE FSE DISCOVERED THAT LMALS (LOWER MEDIAN ANGLE LIGHT SCATTER) OFFSET VOLTAGE WAS ELEVATED. THE FSE REPLACED THE MALS (MEDIAN ANGLE LIGHT SCATTER) SENSOR TO RESOLVE THE ISSUES. THE FSE ALSO REALIGNED THE MULTI-TRANSDUCER MODULE (MTM) AND MONITORED LATRON GAIN CALIBRATIONS AS PART OF INCIDENTAL MAINTENANCE, AND VERIFIED THE INSTRUMENT'S PERFORMANCE. ONE FAILURE MODE WAS RELATED TO THE HGB PREAMPLIFIER IN THE HGB ASSEMBLY AND ANOTHER FAILURE MODE WAS ATTRIBUTED TO THE MALS SENSOR. BECKMAN INTERNAL IDENTIFIER NUMBER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE UNICEL DXH 800 COULTER ANALYZER DXH800 WAS RECOVERING LOW HEMOGLOBIN (HGB) VALUES ON QUALITY CONTROLS (QC) SAMPLES. THE CUSTOMER INDICATED THAT THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED OR REPORTED OUTSIDE OF THE LABORATORY AS THE ISSUES OCCURRED WHILE RUNNING QC. NO DEATH OR INJURY IS ATTRIBUTED TO THIS EVENT AND THERE WAS NO CHANGE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334270 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1