BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AUTOLOADER ANALYZER

    MDR report key: 2001090 · Received February 24, 2011

    Report

    Report Number
    1061932-2011-00102
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K922704
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN A BD VACUTAINER TUBE. CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. PER THE CUSTOMER CONTROLS ARE RUN TWICE PER DAY. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS (ACCURACY) AND REPRODUCIBILITY (PRECISION). A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND WAS UNABLE TO REPRODUCE THE PROBLEM. THE FSE VERIFIED THE DIFFERENTIAL PUMP VOLUMES, RAN REPRODUCIBILITY, AND QC TO VERIFY THE INSTRUMENTS OPERATION. THE ROOT CAUSE FOR THE ERRONEOUS DIFFERENTIAL RESULTS IS UNKNOWN; HOWEVER, THE INSTRUMENT DID GENERATE APPROPRIATE FLAGS TO ALERT THE OPERATOR TO FURTHER REVIEW THE SAMPLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER HMX AUTOLOADER ANALYZER GENERATED ERRONEOUS DIFFERENTIAL RESULTS WITH INSTRUMENT GENERATED FLAGS FOR TWO PATIENT SAMPLES. NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. MANUAL DIFFERENTIALS WERE PERFORMED ON BOTH OF THE SPECIMENS. SPECIMENS WERE ALSO REPEATED ON THE ORIGINAL INSTRUMENT. THE FIRST PATIENT'S SPECIMEN RECOVERED INSTRUMENT GENERATED FLAGS FOR BOTH THE WHITE BLOOD COUNT (WBC) AND DIFFERENTIAL PARAMETERS. THERE WAS NO DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX AUTOLOADER ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER, INC. HMX AL 115V N/A

    Patients

    Seq Age Sex Outcome Treatment
    1