BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT BCR-ABL ULTRA

    MDR report key: 21893005 · Received April 23, 2025

    Report

    Report Number
    3004530258-2025-00016
    Event Type
    Malfunction
    Date Received
    April 23, 2025
    Date of Event
    March 24, 2025
    Report Date
    May 13, 2025
    Manufacturer
    CEPHEID
    Product Code
    OYX
    PMA / PMN Number
    K190076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIRST RESULT IN AN UNEXPECTED OVER QUANTIFICATION. THERE IS A 53-FOLD DIFFERENCE BETWEEN THESE RESULTS WHICH SHOWS A DISCREPANCY. FROM THE CURVE ANALYSIS, THERE IS A BASELINE SHIFT THAT LIKELY CONTRIBUTES TO THE OVERESTIMATION OF RESULTS. NO PATIENT HARM AS RESULTS WERE NOT COMMUNICATED TO THE PHYSICIAN. SINCE THE FIRST RESULT IS ABOVE CLINICALLY RELEVANT MMR (MAJOR MOLECULAR RESPONSE) THRESHOLD (0.1%), PRODUCT MALFUNCTION CANNOT BE EXCLUDED. THE INVESTIGATION IS STILL ONGOING. IN SECTION B1 'PRODUCT PROBLEM' AND SECTION H3 'MALFUNCTION' WERE SELECTED AS THESE SECTIONS ARE REQUIRED FOR SUBMISSION. HOWEVER, THERE IS NOT ENOUGH INFORMATION AT THIS TIME TO MAKE A DETERMINATION. 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.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED UNEXPECTED TEST RESULT FROM ONE PATIENT. TEST RESULT WAS POSITIVE WITH AN UNEXPECTED OVER QUANTIFICATION [0.17% IS; MR 2.77]. THEREFORE, A REPEAT TEST WAS ORDERED. THE REPEAT TEST WAS RUN FROM A SEPARATE BLOOD TUBE COMING FROM THE SAME BLOOD DRAW AS THE FIRST BLOOD SPECIMEN. REPEAT RESULT WAS POSITIVE [0.0032% (IS); MR4.49]. THERE IS A 53-FOLD DIFFERENCE BETWEEN THESE RESULTS WHICH SHOWS A DISCREPANCY. THERE WAS NO ASSOCIATED PATIENT HARM AND ONLY SECOND RESULT WAS CONSIDERED. THE LIKELY ROOT CAUSE OF THIS OVER QUANTITATION IS AN ABERRANT CURVE DUE TO A BASELINE DRIFT. XPERT BCR-ABL ULTRA TEST HAS BEEN USED OUTSIDE OF ITS INTENDED PURPOSE SINCE THE PATIENT WAS NOT ON TKI TREATMENT. THIS IS AN OFF-LABEL USE OF THE DEVICE, THEREFORE THIS CASE DOES NOT MEET THE CRITERIA FOR A SERIOUS INCIDENT AND IS NOT REPORTABLE. SECTION H6 INVESTIGATION FINDINGS AND INVESTIGATIONS CONCLUSIONS CODES HAVE BEEN UPDATED TO REFLECT THE OUTCOME OF THE INVESTIGATION.

    Description of Event or Problem · 0

    ON THE 26-MARCH-2025 A CUSTOMER IN FINLAND HAS REPORTED A DISCREPANT RESULT ON XPERT BCR-ABL ULTRA LOT 42801/1001459091. ON THE (B)(6) 2025 A WHOLE BLOOD SAMPLE WAS COLLECTED FROM PATIENT AND PROCESSED ACCORDING TO XPERT BCR-ABL ULTRA INSTRUCTIONS FOR USE. THE PATIENT WAS PREVIOUSLY DIAGNOSED WITH OR TREATED FOR CML (CHRONIC MYELOGENOUS LEUKEMIA). IF PATIENT WAS ON ANY MEDICATIONS IS NOT KNOWN. ON THE (B)(6) 2025, THE FIRST TUBE COLLECTED GAVE POSITIVE RESULT ON XPERT BCR-ABL ULTRA [0.17% IS (INTERNATIONAL SCALE) AND MR2.77 (MOLECULAR RESPONSE)]. THIS RESULT TIPPED OFF THE CUSTOMER AND THEREFORE HE PLANNED TO RETEST. ON THE (B)(6) 2025, THE SECOND TUBE FROM THE SAME SAMPLE WAS USED AND GAVE POSITIVE RESULT ON XPERT BCR-ABL ULTRA [(B)(4) (IS) AND MR4.49]. THE FOLD DIFFERENCE CALCULATED BETWEEN THE RESULTS IS 53.125. THE RESULT WAS NOT REPORTED TO PHYSICIAN. NO IMPACT ON PATIENT SINCE THE LABORATORY IMMEDIATELY NOTICED THIS DISCREPANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1291150 XPERT BCR-ABL ULTRA XPERT BCR-ABL ULTRA OYX CEPHEID 1001459091

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown