BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH500 HEMATOLOGY ANALYZER

    MDR report key: 3100544 · Received May 8, 2013

    Report

    Report Number
    1061932-2013-00765
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K042724
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLES WERE COLLECTED IN EDTA 5 ML VACUTAINER TUBES. CONTROLS WERE RUN BEFORE THIS EVENT, AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QUALITY CONTROL (QC) SPECIFICATIONS. PREVIOUSLY RUN PATIENT SAMPLES WERE RERUN TO CONFIRM ACCURATE BACK TO THE LAST ACCEPTABLE RUN. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE REPLACED THE BLOOD SAMPLING VALVE (BSV) ACTUATOR, PINCH VALVE (PV23) AND ACTUATOR AND THE PRIMARY ASPIRATION TUBING TO RESOLVE THIS ISSUE. PER CONVERSATION WITH THE CUSTOMER ON (B)(4) 2013, BOTH INSTRUMENTS (LH1 AND LH2) CORRELATE AND THEY HAVE HAD NO FURTHER ISSUES. FAILURE MODE CAN BE ATTRIBUTED TO THE BSV ACTUATOR, PV23 AND ACTUATOR AND THE PRIMARY ASPIRATION TUBING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THEIR COULTER LH500 HEMATOLOGY ANALYZER (LH1) GENERATED LOWER COMPLETE BLOOD COUNT (CBC) RESULTS ON TWO (2) PATIENT SAMPLES WITHOUT INSTRUMENT FLAGS COMPARED TO RERUN AND SAME SAMPLE RUN ON THEIR OTHER LH 500 (LH 2) INSTRUMENT. THE CUSTOMER CONSIDERED THE RERUN CBC RESULTS AND THE CBC RESULTS OBTAINED FROM THE OTHER INSTRUMENT WERE CORRECT. ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY AND THERE WAS NO CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT. THIS REPORT COVERS THE CBC RESULTS FOR PATIENT TWO (2), GENERATED ON (B)(6) 2013. MDR# 1061932-2013-00764 IS TO REPORT RESULTS FOR PATIENT ONE (1) ANALYZED ON THE LH 500 INSTRUMENT ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202087 COULTER® LH500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER LH 500 NA

    Patients

    Seq Age Sex Outcome Treatment
    1