BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BECKMAN COULTER ¿ COULTER ® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2834535 · Received November 15, 2012

    Report

    Report Number
    1061932-2012-02669
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 20, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS ON SITE AND FOUND THE TUBING WAS OLD AND LOOSENED AT THE FITTING TO THE WBC BATH TO HAVE A LEAK. THE FSE DID NOT OBSERVE A LEAK BUT DID NOTE DRIED REAGENT ON THE TUBING AT THE FITTING INDICATING A PREVIOUS LEAK OF CLENZ. THE FSE CHANGED THE TUBING FROM Y-FITTING FY21A TO THE WBC BATH, VC3, AS WELL AS ACTUATORS 12A, 12B, 12D, 12F, 6, AND 4A TO ENSURE PROPER FLOW THE FITTING TO RESOLVE THE LEAK AND INTERMITTENT HIGH HEMOGLOBIN RESULT ISSUE. THE FAILURE MODE OF THE EVENT WAS THE FITTING FROM THE WBC BATH FROM FY21-A (FITTING 21-A) AND VC3 (VACUUM CHAMBER 3).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED INTERMITTENT HIGH HEMOGLOBIN RESULTS GENERATED BY THE COULTER LH 750 HEMATOLOGY ANALYZER FOR THREE PATIENTS WHEN COMPARED TO 2 RERUNS ON 2 ADDITIONAL LH 750 INSTRUMENTS, WHICH THE CUSTOMER CONSIDERED CORRECT. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY; HOWEVER, PATIENT TREATMENT AS NOT AFFECTED BY THE EVENT. THE RESULTS AMENDED ARE REPORTED. DATA REVIEW SHOWED THE ORIGINAL RUNS ON THE FIRST LH750 (SN (B)(4)) GENERATED ERRONEOUS HEMOGLOBIN, MCH AND MCHC RESULTS. EACH PATIENT SAMPLE WAS RUN ON A SECOND AND THIRD LH 750 INSTRUMENT WITH SIMILAR CORRECT RESULTS OBTAINED FOR EACH PARAMETER REPORTED. THE CUSTOMER ONLY PROVIDED LIS PRINTOUTS THEREFORE FLAGGING COULD NOT BE ASSESSED. RAW DATA HAS BEEN REQUESTED BUT IS NO LONGER AVAILABLE THIS MDR DOCUMENTS THE EVENT FROM PATIENT #1 WHICH WAS ANALYZED ON (B)(4) 2012. THE EVENT OF (B)(6) 2012, ARE DOCUMENTED IN MDR 1061932-2012-02670 AND 1016932-2012-02671, RESPECTIVELY. PATIENT 1 WAS ANALYZED ON (B)(6) 2012, ON LH750 (SN AL26235) AND THE SAMPLE WAS RERUN ON (B)(6) 2012 ON 2 ADDITIONAL LH750 INSTRUMENTS (SN (B)(4)). PLEASE REFER TO THE ATTACHED PATIENT RESULTS. THE CUSTOMER DID NOT PROVIDE PATIENT DEMOGRAPHIC OR SAMPLE INFORMATION. PER CUSTOMER, CONTROLS WERE RAN BEFORE AND AFTER THE EVENT AND RECOVERED WITHIN RANGE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1