BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XN-10

    MDR report key: 10923033 · Received November 30, 2020

    Report

    Report Number
    1000515253-2020-00031
    Event Type
    Injury
    Date Received
    November 30, 2020
    Date of Event
    November 11, 2020
    Report Date
    November 30, 2020
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER 'S INVESTIGATION CONFIRMED THE SPECIMEN HAD AN INCORRECT SAMPLE IDENTIFICATION BARCODE LABEL AND WAS PROCESSED ON THE ANALYZER. GOOD LABORATORY PRACTICE REQUIRES THAT THE USER PROPERLY IDENTIFY SAMPLES. THE MISLABELED SAMPLE GENERATED A POSITIVE JUDGEMENT WITH INTERPRETIVE PROGRAM (IP) MESSAGE FLAGS. THE XN-10 IS INTENDED FOR IN VITRO DIAGNOSTIC USE IN SCREENING PATIENT POPULATIONS FOUND IN CLINICAL LABORATORIES. VALUES OBTAINED IN CBC ANALYSIS ARE USED IN CONJUNCTION WITH OTHER CLINICAL SIGNS AND SYMPTOMS TO DETERMINE PATIENT DIAGNOSIS AND TREATMENT. GOOD LABORATORY PRACTICE REQUIRES THAT A SYSTEM BE IN PLACE FOR CONFIRMING AND REPORTING CRITICAL VALUES AND/OR SIGNIFICANT CHANGES IN THE PATIENT TEST RESULTS (DELTA CHECKS, PREVIOUS RESULT REVIEWS, VERIFICATION BY ANOTHER METHOD, PERIPHERAL SMEAR EXAMINATION, ETC.). THE USER'S HEMATOLOGY SYSTEM GENERATED A DELTA CHECK FOR THE ERRONEOUS HGB RESULT. THE PURPOSE OF DELTA CHECKING IS TO JUDGE IF THE DATA IS ABNORMAL OR NOT BASED ON THE VARIATION BETWEEN THE LATEST DATA AND THE PREVIOUSLY ANALYZED DATA. THE USER FAILED TO INVESTIGATE THE DELTA CHECK OR CONFIRM ACCURACY OF POSITIVE JUDGEMENT PRIOR TO RELEASE OF RESULTS. NO ANALYZER DEFICIENCIES WERE IDENTIFIED.

    Description of Event or Problem · 1

    THE USER REPORTED A MISLABELED PATIENT SAMPLE WAS ANALYZED FOR A COMPLETE BLOOD COUNT AND DIFFERENTIAL (CBC/DIFF) AND ERRONEOUS RESULTS FROM THE MISLABELED SAMPLE WERE REPORTED. THE CORRECTLY LABELED SAMPLE FROM THE PATIENT WAS ANALYZED AFTER THE MISLABELED SAMPLE IN THE SAME RACK, HOWEVER THE CORRECT RESULTS DID NOT FILE TO THE LABORATORY INFORMATION SYSTEM (LIS) SINCE THE SAMPLE ID HAD ALREADY BEEN REPORTED WITH THE ERRONEOUS RESULTS FROM THE MISLABELED SAMPLE. THE PATIENT, WHOSE SAMPLE ID HAD BEEN ERRONEOUSLY AFFIXED TO ANOTHER PATIENT'S SAMPLE, RECEIVED AN UNNECESSARY TRANSFUSION OF TWO UNITS OF PACKED RED BLOOD CELLS (PRBCS) DUE TO AN ERRONEOUS LOW HEMOGLOBIN (HGB) RESULT. THE PATIENT UNDERWENT AN UNNECESSARY COLONOSCOPY AND ENDOSCOPY. NO HARM TO THE PATIENT WAS REPORTED DUE TO THE TRANSFUSION OR PROCEDURES. THE USER BECAME AWARE OF THE SAMPLE ID DISCREPANCY LATER IN THE DAY, WHEN REVIEWING RESULTS AND INVESTIGATING A HGB DELTA CHECK FOR THE MISLABELED SAMPLE. A CORRECTED REPORT WAS ISSUED THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1388961 SYSMEX XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other