BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX AUTOLOADER ANALYZER

    MDR report key: 1911186 · Received November 30, 2010

    Report

    Report Number
    1061932-2010-00233
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 1, 2010
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN 4 AND 2 ML BD VACUTAINER TUBES. THE SPECIMENS WERE 2 HOURS OLD WHEN SAMPLED AND STORED AT ROOM TEMPERATURE. SAMPLES WERE RERUN BACK TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE INSTRUMENT IS CURRENTLY RUNNING WITHIN QC SPECIFICATIONS. CONTROLS WERE RUN BEFORE NOT AFTER THIS INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(6) 2010 FOR THIS EVENT. THE FSE PERFORMED TROUBLESHOOTING, REPLACED SOME HARDWARE, AND VERIFIED. THE FSE ALSO VERIFIED THE INSTRUMENT ASPIRATION, ADJUSTED THE CALIBRATION FACTORS, PERFORMED A STARTUP, RAN CONTROLS, AND PERFORMED REPRODUCIBILITY IN BOTH MODES. THE ROOT CAUSE IS UNKNOWN. PER BCI LABELING, BECKMAN COULTER INC. DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BCI SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON THE PATIENT POPULATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER HMX AUTOLOADER ANALYZER GENERATED ERRONEOUSLY HIGH HEMOGLOBIN (HGB) AND LOW RED BLOOD COUNT (RBC), MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS ON 7 PATIENT SAMPLES WITH NO INSTRUMENT GENERATED FLAGS. FOUR PATIENT RESULTS WERE PROVIDED BY THE CUSTOMER AND ARE SHOWN. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. NONE OF THE PROVIDED SPECIMEN RESULTS WERE REPEATED. THERE WAS NO DEATH, SERIOUS INJURY, OR CHANGE TO PATIENT TREATMENT IN 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