BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AUTOLOADER

    MDR report key: 2030060 · Received March 25, 2011

    Report

    Report Number
    1061932-2011-00177
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K922704
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE IS COLLECTED VIA VENIPUNCTURE ON 5ML BD VACUTAINER. QC RUN BEFORE AND AFTER THE EVENT RECOVERED WITHIN RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE, PERFORMED TROUBLESHOOTING AND REPLACED SOME HARDWARE. A CLEAR ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING THAT THE COULTER HMX AUTOLOADER INSTRUMENT INTERMITTENTLY GENERATED ERRONEOUS HIGH BASOPHIL (BA%) ON PATIENT SAMPLES WHEN COMPARED TO MANUAL SMEAR AND SAMPLE RERUN. THE ACTUAL PATIENT DATA WAS NOT PROVIDED. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT WITH REGARD TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1