BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2365284 · Received December 9, 2011

    Report

    Report Number
    1061932-2011-02534
    Event Type
    Injury
    Date Received
    December 9, 2011
    Date of Event
    November 17, 2011
    Report Date
    November 17, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) DISCOVERED THAT THE ACTUATORS FOR PINCH VALVES VL4 AND VL6 WERE NOT FUNCTIONING PROPERLY. THE ACTUATORS FOR BOTH VALVES WERE REPLACED. THE REPAIR WAS VERIFIED AND SYSTEM VALIDATED PRIOR TO RETURNING THE INSTRUMENT BACK INTO OPERATION. THE ROOT CAUSE OF THE GENERATED ERRONEOUS RESULTS APPEARS TO BE HARDWARE RELATED. THE ROOT CAUSE OF THE REPORTING OF THE ERRONEOUS RESULTS WAS USE ERROR. BECKMAN COULTER INC. LABELING INDICATES THAT THEY SHOULD BE CONTACTED IN THE INSTANCE OF DAILY CHECK FAILURES. MDRS ASSOCIATED WITH THIS EVENT: 1061932-2011-02532, 1061932-2011-02533, 1061932-2011-02534, 1061932-2011-02535.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT A COULTER LH 750 HEMATOLOGY ANALYZER GENERATED ERRONEOUS LOW HEMOGLOBIN (HGB) RESULTS WITH NO INSTRUMENT GENERATED FLAGS FOR MULTIPLE PATIENT SAMPLES OVER TWO DAYS. INSTRUMENT DAILY CHECKS FAILED ON STARTUP FOR HGB DURING THE TIMEFRAME OF THIS EVENT. DAILY CHECKS VERIFY AND CONFIRM IF THE STARTUP TESTS PASS. IF THE DAILY CHECK BACKGROUND FAILS, THEN, PER LABELING, THE CUSTOMER SHOULD CONTACT BECKMAN COULTER. DESPITE FAILING DAILY CHECKS, THE CUSTOMER CONTINUED TO OPERATE AND REPORT OUT PATIENT RESULTS. THIS IS REPORT THREE OF FOUR AND REPRESENTS THE ERRONEOUSLY ELEVATED HGB RESULT GENERATED ON A COULTER LH 750 HEMATOLOGY ANALYZER FOR ONE PATIENT ON (B)(6) 2011. THE SAMPLE WAS RERUN, YIELDING A HIGHER HGB REPEAT RESULT WHICH THE CUSTOMER CONSIDERED CORRECT. THE INITIAL ERRONEOUS HGB RESULT WAS REPORTED OUTSIDE OF THE LABORATORY AND THE PATIENT WAS TRANSFUSED WITH ONE UNIT OF BLOOD BASED UPON THE ERRONEOUS HGB RESULT. NO SPECIFIC PATIENT INFORMATION OR SAMPLE COLLECTION/HANDLING INFORMATION WAS PROVIDED BY THE CUSTOMER. CONTROLS WERE EXECUTED BEFORE THE INCIDENT AND WERE WITHIN THE EXPECTED RANGE. THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention