BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT BCR-ABL ULTRA

    MDR report key: 22179308 · Received June 10, 2025

    Report

    Report Number
    3004530258-2025-00021
    Event Type
    Malfunction
    Date Received
    June 10, 2025
    Date of Event
    May 10, 2025
    Report Date
    June 10, 2025
    Manufacturer
    CEPHEID
    Product Code
    OYX
    PMA / PMN Number
    K190076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISTRIBUTOR REPORTED AN UNEXPECTED TEST RESULT FROM ONE PATIENT AT A CUSTOMER SITE. THIS PATIENT WAS A CONFIRMED E13A2 (B2A2) P210 CML PATIENT DIAGNOSED SEVERAL MONTHS AGO. THE FIRST MONITORING TEST WAS PERFORMED AT REFERENCE CENTER IN THE US (SAMPLE WAS SHIPPED TO THE US AS THIS PATIENT IS TAKING PART IN CLINICAL TRIAL). THE TEST RESULT WAS POSITIVE [MR > 3]. AS PATIENT WAS SUBMITTED TO CUSTOMER SITE, THE TEST WAS RAN INTERNALLY WITH XPERT BCR-ABL ULTRA ON (B)(6) 2025 AND RESULT WAS POSITIVE [0.048% IS; MR3.32]. SINCE THIS RESULT WAS UNEXPECTEDLY LOW, THE LAB HAS REPEATED THE TEST ON (B)(6) 2025 WITH EXTRACTED RNA WITH TWO ALTERNATIVE RT-QPCR BASED METHODS (ABI AND DIATECH). TEST RESULTS WERE: ABI: 0.394% ABL1 COPIES 2.21 X 10^4; BCR-ABL1 COPIES 153; 8 FOLD DIFFERENCE BETWEEN ABI/CEPHEID METHODS; DIATECH: 0.1863% ABL1 COPIES 54,213; 3.9 FOLD DIFFERENCE BETWEEN DIATECH/CEPHEID METHODS. WHILE CEPHEID RESULT INDICATES THAT THIS PATIENT IS IN MMR, THE OTHER TWO TESTS ARE AT MR> 3 (MMR NOT REACHED). ACCORDING TO ELN GUIDELINES FOR CML, MMR SHOULD BE REACHED WITHIN A YEAR OF STARTING THE TKI THERAPY. CUSTOMER HAD NO LYSATE RETAINED TO BE ABLE TO PERFORM REPEAT TESTING. THERE WAS NO PATIENT IMPACT DUE TO THIS DISCREPANCY, NO CLINICAL DECISION HAS BEEN MADE BASED ON CEPHEID TEST RESULT. NO CHANGES TO THERAPY WERE ALSO IMPLEMENTED AFTER THE REPEAT TEST RESULTS WERE GIVEN TO THE TREATING PHYSICIAN. INTERNAL QUALITY CONTROL, RELEASE DATA AND CUSTOMER COMPLAINT DATA DO NOT INDICATE THAT THERE IS SYSTEMIC 42001 LOT MALFUNCTION. THERE WAS NO IMPACT ON PATIENT, HOWEVER THE ROOT CAUSE IS INCONCLUSIVE: IT COULD EITHER BE PATIENT SPECIMEN-SPECIFIC OR AN ISOLATED CARTRIDGE ISSUE.. ADDITIONAL TESTING COULD NOT BE PERFORMED BECAUSE THERE WERE NO SAMPLE LEFTOVERS. NOTE FOR SECTION H3 DEVICE EVALUATED BY MANUFACTURER - ANSWER OF NO IS DUE TO THE SINGLE USE OF THE XPERT BCR-ABL ULTRA TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.

    Description of Event or Problem · 0

    ON THE 12-MAY-2025, THE CUSTOMER REPORTED A DISCREPANT RESULT ON XPERT BCR-ABL ULTRA LOT 42001/1001447302. THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH CHRONIC MYELOID LEUKEMIA (CML) CHARACTERIZED BY THE T(9;22) TRANSLOCATION AND IS CURRENTLY UNDERGOING ACTIVE TREATMENT, ALTHOUGH NO DETAILS ABOUT THE THERAPY HAVE BEEN DISCLOSED. THE PATIENT WAS DIAGNOSED A FEW MONTHS AGO AND HAS NOT YET REACHED MAJOR MOLECULAR RESPONSE (MMR). ON (B)(6) 2025, THE SAMPLE WAS TESTED USING XPERT BCR-ABL ULTRA ASSAY LOT 42001/1001447302 AND THE RESULT WAS POSITIVE, WITH AN INTERNATIONAL SCALE (IS) VALUE OF 0.048% AND A MOLECULAR RESPONSE (MR) OF 3.32. THIS RESULT WAS NOT REPORTED TO THE PHYSICIAN DUE TO THE PATIENT'S ADMISSION TO THE HEMATOLOGY CLINIC, CONFIRMATION TESTING WAS REQUESTED. ON THE SAME DAY, THE LABORATORY PERFORMED ADDITIONAL TESTING USING TWO DIFFERENT CE-IVD VALIDATED METHODS ON THE SAME SAMPLE. THE FIRST METHOD, ABI (APPLIED BIOSYSTEMS), YIELDED A POSITIVE RESULT WITH AN IS OF 0.394%, ABL (ABELSON GENE) COPIES OF 2.21 × 10 (4), AND BCR (BREAKPOINT CLUSTER REGION) COPIES OF 153. THE SECOND METHOD, DIATECH, ALSO RETURNED A POSITIVE RESULT WITH AN IS OF 0.1863% AND AN ABL SUM OF 54,213. THESE RESULTS WERE CONSISTENT WITH THOSE OBTAINED BY THE REFERENCE CENTER IN THE UNITED STATES, ALTHOUGH THE EXACT VALUES FROM THE REFERENCE CENTER WERE NOT DISCLOSED. THE CUSTOMER CONFIRMED THAT ALL THREE TESTS (THE XPERT BCR-ABL ULTRA, ABI AND DIATECH) WERE PERFORMED WITH THE SAME SAMPLE. THEY HAD PREVIOUSLY CONDUCTED A VERIFICATION STUDY COMPARING THESE METHODS TO THE XPERT BCR-ABL ULTRA, AND QUANTIFICATION HAD BEEN COMPARABLE. THIS WAS THE FIRST DISCREPANCY THEY HAD EXPERIENCED WITH THE XPERT ASSAY. DESPITE THE UNDER QUANTIFIED RESULT FROM THE XPERT TEST, THERE WAS NO IMPACT ON THE PATIENT. THE PATIENT'S THERAPY WAS NOT ALTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151899 XPERT BCR-ABL ULTRA XPERT BCR-ABL ULTRA OYX CEPHEID 1001447302

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown