BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT BCR-ABL ULTRA

    MDR report key: 24724285 · Received March 30, 2026

    Report

    Report Number
    3004530258-2026-00003
    Event Type
    Malfunction
    Date Received
    March 30, 2026
    Date of Event
    February 27, 2026
    Report Date
    March 29, 2026
    Manufacturer
    CEPHEID
    Product Code
    OYX
    PMA / PMN Number
    K190076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WHITE BLOOD CELL COUNT WAS WITHIN THE NORMAL RANGE (4-10 MLN/ML). SAMPLE STORAGE, AND SAMPLE PREPARATION WERE DONE ACCORDING TO THE INSTRUCTIONS FOR USE. SAMPLE WAS STORED AT 4C FOR 4 HOURS. XPERT BCR-ABL ULTRA TEST RESULT WAS NEGATIVE [SUFFICIENT ABL TRANSCRIPT]. TEST RESULT WAS REPORTED TO THE CLINICIAN BUT AS IT DID NOT MATCH PATIENT HISTORY, THE DOCTOR REQUESTED A RETEST. IT WAS PERFORMED ON THE SAME BLOOD SPECIMEN (STORED AT 4C) ON (B)(6) 2026. THE RESULT WAS POSITIVE [0.026%IS; MR3.59]. THE RETEST WAS SIGNIFICANTLY HIGHER THAN THE FIRST TEST. THERE WAS NO PATIENT IMPACT DUE TO THIS DISCREPANCY AS CONFIRMED BY THE USER. DATA PROVIDED BY THE CUSTOMER ARE INCONCLUSIVE, BUT A SAMPLE MIX-UP OR A SINGLE CARTRIDGE DEFECT CANNOT BE EXCLUDED. REVIEW OF PRODUCTION RECORDS (INCLUDING INTERNAL QUALITY CONTROL) CONFIRMED THAT PRODUCT MEETS RELEASE SPECIFICATIONS. REVIEW OF CUSTOMER COMPLAINTS RELATED TO THE SAME LOT DO NOT INDICATE SYSTEMIC LOT MALFUNCTION. THE ROOT CAUSE OF THIS UNDER QUANTITATION IS INCONCLUSIVE. THE CASE IS DEEMED REPORTABLE.

    Description of Event or Problem · 0

    ON (B)(6) 2026, A CUSTOMER REPORTED AN INCIDENT TO CEPHEID REGARDING A QUESTIONABLE NEGATIVE RESULT ON A PATIENT OBTAINED WITH THE XPERT BCR[?]ABL ULTRA ASSAY (LOT 45301/1001495811). ON (B)(6) 2026, A WHOLE BLOOD SAMPLE WAS COLLECTED FROM AN ADULT PATIENT WHO HAD PREVIOUSLY BEEN DIAGNOSED WITH T (9;22) POSITIVE CHRONIC MYELOID LEUKEMIA (CML) AND WAS UNDERGOING ACTIVE TREATMENT (TKI THERAPY). THE CONTEXT IS A ROUTINE FOLLOW-UP VISIT. THE SAMPLE WAS COLLECTED IN AN EDTA STERILE TUBE. ON (B)(6) 2026, THE SAMPLE WAS TESTED USING THE XPERT BCR ABL ULTRA ASSAY (LOT 45301). THE TEST GAVE A NEGATIVE RESULT WITH SUFFICIENT ABL TRANSCRIPT. THIS RESULT DID NOT FIT THE PATIENT'S CLINICAL HISTORY; HENCE THE CLINICIAN REQUESTED AN ADDITIONAL TEST. ON (B)(6) 2026, THE SAME SAMPLE WAS RETESTED USING THE SAME ASSAY AND LOT NUMBER (DUE TO THE DISCREPANCY). THE RETEST GAVE A POSITIVE RESULT [0.026% (IS) AND MR3.59], AND THIS RESULT WAS ALSO REPORTED TO THE PHYSICIAN. THE CALCULATED FOLD DIFFERENCE BETWEEN THE FIRST AND SECOND RESULTS (8.6 FOLD DIFFERENCE) EXCEEDED THE ACCEPTABLE THREE FOLD VARIABILITY FOR REPEAT TESTING, CONFIRMING THE DISCREPANT RESULT. THERE WAS NO HARM TO THE PATIENT, BUT THERE WAS A DELAY IN DIAGNOSIS FROM INITIAL FEEDBACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276757 XPERT BCR-ABL ULTRA XPERT BCR-ABL ULTRA OYX CEPHEID 1001495811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown