BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 1980923 · Received February 7, 2011

    Report

    Report Number
    1061932-2011-00069
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 9, 2011
    Report Date
    January 10, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS COLLECTED IN 4ML BD VACUTAINER TUBE AND STORED AT ROOM TEMPERATURE FOR FEW HOURS BEFORE PROCESSING IN THE PRIMARY MODE. CONTROLS WERE RUN IMMEDIATELY PRIOR AND AFTER THE INCIDENT AND RECOVERED WITHIN ASSAY LIMITS. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND NOTICED THAT THE RED BLOOD COUNT (RBC) APERTURE ELECTRODE WAS LOOSE AND REPLACED IT. THE FSE SUGGESTED THAT THE POSSIBLE CAUSE WAS A FAULTY CIRCUIT CARD PERTAINING TO THE PLATELET COUNT. THE FSE ORDERED AND RETURNED TO SITE TO REPLACE 3 CIRCUIT CARDS ASSOCIATED WITH PLATELET PROCESSING AND CHECKED CALIBRATIONS. THE FSE SUGGESTED THAT CUSTOMER SET UP DELTA CHECKS RULES IN REMISOL ON THE PLATELET PARAMETER TO TRY AND CAPTURE ANY FUTURE EPISODES. ROOT CAUSE IS UNKNOWN TO DATE. PER LABELING, BECKMAN COULTER INC DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BECKMAN COULTER INC SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON YOUR PATIENT POPULATION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT THE COULTER LH 780 HEMATOLOGY ANALYZER GENERATED ERRONEOUSLY HIGH PLATELET (PLT) RESULTS WITH AN OPERATOR-DEFINED FLAG ON A SINGLE PATIENT SAMPLE. THE ERRONEOUSLY HIGH PLT RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER QUESTIONED THE RESULTS BECAUSE THE RESULTS OBTAINED WERE NOT CONSISTENT WITH THE PATIENT'S HISTORY (LOWER PLATELET COUNTS). THE SAMPLE WAS RE-ANALYZED ON (B)(4) 2011 AND RECOVERED THE EXPECTED LOWER PLATELET RESULTS AND AMENDED REPORTS WERE ISSUED. THERE WAS NO DEATH, INJURY, OR AFFECT TO PATIENT TREATMENT THAT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® LH 780 HEMATOLOGY ANALYZER HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. LH 780 NA

    Patients

    Seq Age Sex Outcome Treatment
    1