BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 ANALYZER

    MDR report key: 2001974 · Received February 27, 2011

    Report

    Report Number
    1061932-2011-00096
    Event Type
    Malfunction
    Date Received
    February 27, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 29, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER REVIEW OF THE DATA BY THE FIELD SERVICE ENGINEER (FSE), THE SAMPLES WERE NOT DILUTED. FSE PERFORMED TROUBLESHOOTING AND FOUND CRIMPED TUBING ON THE DRAIN LINE AND A PLUGGED VACUUM LINE AND PERFORMED REPAIRS AS NECESSARY AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REPORTING LOW PATIENT RESULTS GENERATED BY THE COULTER LH500 ANALYZER FOR SIX PATIENTS. THE RESULTS WERE FLAGGED VIA DELTA CHECKS. TWO OF THE SIX PATIENTS WERE REPORTED OUTSIDE OF THE LABORATORY. ALL 6 PATIENTS WERE REDRAWN AND RECOVERED RESULTS THAT MATCHED THEIR CLINICAL DATA. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO OR CONNECTED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH500 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. LH500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1