BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT BCR-ABL ULTRA

    MDR report key: 23251305 · Received October 8, 2025

    Report

    Report Number
    3004530258-2025-00032
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    August 29, 2025
    Report Date
    October 8, 2025
    Manufacturer
    CEPHEID
    Product Code
    QIG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REFERENCE LABORATORY IS A HIGH-VOLUME TESTING FACILITY THAT TYPICALLY RECEIVES LIMITED CLINICAL INFORMATION WITH SUBMITTED SAMPLES, INCLUDING DETAILS REGARDING THE PATIENT'S POSITION WITHIN THE DIAGNOSTIC PATHWAY (E.G., DETECTION OR MONITORING). ADDITIONALLY, THE CUSTOMER DOES NOT ROUTINELY PERFORM WHITE BLOOD CELL (WBC) COUNTS NOR RECEIVE THIS DATA FROM ORDERING PHYSICIANS. BOTH PATIENT SPECIMENS WERE CHARACTERIZED BY MARKEDLY ELEVATED WBC COUNTS (>100 MIO/ML). OF THE TWO PATIENTS REPORTED, ONE WAS CONFIRMED AS BEING MONITORED, FOLLOWING CLINICIAN FEEDBACK INDICATING THE INITIAL TEST RESULT DIFFERED SIGNIFICANTLY FROM THE PRIOR MONITORING SAMPLE, WHICH HAD MEASURED APPROXIMATELY 16% IS. THE SECOND CASE INVOLVED A DIAGNOSTIC PATIENT (OFF-LABEL USE), FOR WHOM THE CLINICIAN REQUESTED A RETEST DUE TO AN UNEXPECTEDLY LOW RESULT. IN BOTH CASES, RETEST RESULTS WERE COMMUNICATED TO CLINICIANS, AND THERE WAS NO IMPACT ON PATIENT CARE. THE CUSTOMER NOTED THAT LYSATES FOR THESE TWO SPECIMENS WERE VISCOUS AND NON-HOMOGENOUS SUPPORTING THE CONCLUSION THAT SYSTEM OVERLOADING AND INEFFICIENT CELL LYSIS - LIKELY RESULTING FROM MARKEDLY INCREASED WBC COUNTS CONTRIBUTED TO UNEVEN TARGET DISTRIBUTION AND BCR::ABL1 TRANSCRIPT UNDER QUANTIFICATION. WHILE THE TEST'S LIMITATIONS SECTION IN THE IFU ADVISES USERS THAT SAMPLES WITH ELEVATED WBC COUNTS (>30 MIO/ML) MAY YIELD INVALID RESULTS, IN THESE INSTANCES THE REPORTED RESULTS WERE CONSIDERED VALID. THE LIKELY ROOT CAUSE OF THIS MIS-QUANTIFICATION IS INCOMPLETE CELL LYSIS DUE TO HIGH WBC COUNT SAMPLE LEADING TO SYSTEM OVERLOADING. NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE EXPERT BCR-ABL ULTRA TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED CEPHEID TO REPORT A POTENTIAL MIS QUANTITATION FOR TWO PATIENTS TESTED WITH XPERT BCR-ABL ULTRA. THE CUSTOMER IS A REFERENCE LABORATORY AND RECEIVED LIMITED INFORMATION ABOUT PATIENT 1 OR PATIENT 2 CLINICAL AND TREATMENT STATUS FROM THE PROVIDER. AS STATED BY THE CUSTOMER, ONE PATIENT WAS A MONITORING PATIENT, THE SECOND PATIENT COULD HAVE BEEN A NEW DIAGNOSTIC PATIENT. THE CUSTOMER'S CONCERN IS THAT BOTH PATIENTS HAD ELEVATED WHITE BLOOD CELL (WBC), AND THEY ARE CONCERNED ABOUT FALSE NEGATIVE OR FALSE LOW POSITIVE RESULTS FOR THESE SAMPLE TYPES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513625 XPERT BCR-ABL ULTRA XPERT BCR-ABL ULTRA QIG CEPHEID 1001480637

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown