BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 4014863 · Received August 18, 2014

    Report

    Report Number
    1061932-2014-01918
    Event Type
    Injury
    Date Received
    August 18, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE EVALUATED THE INSTRUMENT AND REPLACED THE BLOOD SAMPLING VALVE (BSV) TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING ERRONEOUSLY LOW RESULTS FROM THE LH 500 HEMATOLOGY ANALYZER FOR TWO (2) DIFFERENT PATIENT SAMPLES WHICH WERE RUN ON DIFFERENT DAYS. THIS REPORT REFERENCES THE EVENT WHICH OCCURRED ON (B)(6) 2014 FOR PATIENT #1; PLEASE REFER TO 1061932-2014-01919 FOR THE EVENT WHICH OCCURRED ON (B)(6) 2014 FOR PATIENT #2. THE CUSTOMER REPORTED THE ERRONEOUS RESULTS OUT OF THE LABORATORY FOR PATIENT #1 AND THE PATIENT WAS TRANSFUSED BASED ON THE RELEASED RESULTS. A REVIEW OF THE PROVIDED DATA INDICATES THAT LOWER WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), HEMOGLOBIN (HGB), HEMATOCRIT (HCT), AND PLATELET (PLT) RESULTS WITHOUT INSTRUMENT-GENERATED SPECIFIC FLAGS WERE RECOVERED FOR PATIENT #1. THE ERRONEOUS RESULTS HAD TRIGGERED A DELTA CHECK BUT THE RESULT WAS AUTO-VALIDATED AND RELEASED OUT OF THE LABORATORY. THE CUSTOMER STATED THAT THEIR LABORATORY PROTOCOL IS TO RERUN DELTA CHECKED RESULTS FOR VERIFICATION. THE CUSTOMER REPEATED THE SAMPLE FOR THREE (3) ADDITIONAL TIMES AND THE INSTRUMENT GENERATED INSTRUMENT-SPECIFIC FLAGS THE FIRST AND SECOND RERUN. THE THIRD RERUN WAS CONSIDERED CORRECT BY THE CUSTOMER AND WAS OBTAINED WITHIN THIRTY (30) MINUTES OF THE INITIAL RUN. HOWEVER, THE PHYSICIAN WAS NOT ALERTED TO THE CORRECT RESULTS UNTIL THE FOLLOWING DAY AND THE PATIENT HAD ALREADY BEEN TRANSFUSED WHEN THE HGB RESULT POST TRANSFUSION WAS QUESTIONED BY THE PHYSICIAN. THE LABORATORY REALIZED THAT CORRECT RERUN RESULTS WERE NOT COMMUNICATED TO THE PHYSICIAN ON THE DAY THEY WERE OBTAINED. THE CUSTOMER STATED THAT THERE WAS NO REPORT OF ADVERSE REACTION TO THE PATIENT AS A RESULT OF THE TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493101 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other