BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4123423 · Received September 26, 2014

    Report

    Report Number
    1061932-2014-02456
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    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

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT. THE FSE REPLACED THE RED BLOOD CELL (RBC) BATH ASSEMBLY TO RESOLVE THE PLT AND MPV ISSUES. THE FSE FOUND THE STABILIZE VOLUME DISPENSE WAS INCONSISTENT AND FOUND AIR TRAPPED IN THE PUMP INPUT LINE. THE FSE REPLACED THE STABILIZE PUMP AND ADJUSTED THE SETTINGS PER ESTABLISHED PROCEDURES; THE PC2 ERRORS WERE RESOLVED. THE R FLAG ISSUE REMAINED UNRESOLVED. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A COULTER LH 500 HEMATOLOGY ANALYZER GENERATED DIFFERENTIAL R FLAGS, PLATELET (PLT) VOTEOUTS, ERRATIC MEAN PLATELET VOLUME (MPV) RECOVERY, AND PARTIAL CLOG 2 (PC2) FLAGS WHILE PROCESSING CONTROL AND/OR SAMPLES. THERE WERE NO ERRONEOUS NUMERIC RESULTS GENERATED AND PATIENT TREATMENT WAS NOT IMPACTED IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600315 COULTER LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1