BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER LH 750 ANALYZER

    MDR report key: 2030110 · Received March 26, 2011

    Report

    Report Number
    1061932-2011-00194
    Event Type
    Malfunction
    Date Received
    March 26, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    LOQ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMENS WERE COLLECTED IN EDTA VACUTAINERS. THE INSTRUMENT IS CURRENTLY WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. THE CONTROLS ARE RUN ONCE PER SHIFT. PATIENT CONTROLS ARE ALSO RUN THROUGHOUT EACH SHIFT. CONTROLS WERE RUN BEFORE AND AFTER THE INCIDENT AND RECOVERED WITHIN RANGE. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND BLEACHED THE RED BLOOD COUNT (RBC) / PLATELET (PLT) APERTURES AND RAN THE LATEX/FLOW RATE MATCHING PROCEDURE WITH NO ISSUES. THE FSE ALSO RAN ALL VERIFICATIONS WHICH ALL PASSED SUCCESSFULLY. PER THE CUSTOMER, THE INSTRUMENT IS OPERATING ADEQUATELY SINCE THE SERVICE VISIT AND THAT THE LAB IS DOING MANUAL SMEAR ON PLT COUNTS UNDER 150.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE COULTER LH 750 ANALYZER GENERATED AN ERRONEOUSLY LOW PLATELET (PLT) RESULT THAT WAS REPORTED OUT OF THE LABORATORY. THE PATIENT'S ACTUAL INITIAL PLT RESULT WAS NOT PROVIDED BY THE CUSTOMER. PLT CLUMPS WERE FOUND PRIOR TO REPORTING ERRONEOUS RESULTS. WHEN PLT CLUMPS WERE SEEN ON SMEARS, THE INITIAL RESULT WAS REPORTED AS "PLT COUNT IS DECREASE BY SMEAR REVIEW". THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT REPORTED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 ANALYZER AUTOMATED DIFFERENTIAL CELL COUNTER LOQ BECKMAN COULTER, INC. LH 750 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1