BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3892543 · Received June 24, 2014

    Report

    Report Number
    1061932-2014-01417
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 30, 2014
    Report Date
    May 30, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND FOUND THE RETIC (RETICULOCYTE) STAIN CHAMBER (VC24) WAS NOT DRAINING COMPLETELY AND REPLACED THE 3 TUBE PINCH VALVE, VL53, WHICH WAS REPORTEDLY 'CRACKED AT THE NECK'. (B)(4).

    Description of Event or Problem · 1

    WHILE SERVICING A COULTER LH 750 HEMATOLOGY ANALYZER IN A CUSTOMER'S FACILITY, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) IDENTIFIED THAT RETICULOCYTE TEST RESULTS WERE NOT BEING GENERATED AND THE RETICULOCYTE STAIN CHAMBER WAS NOT DRAINING COMPLETELY. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367798 COULTER LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1