BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT BCR-ABL ULTRA

    MDR report key: 21563819 · Received March 10, 2025

    Report

    Report Number
    3004530258-2025-00008
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    February 4, 2025
    Report Date
    April 25, 2025
    Manufacturer
    CEPHEID
    Product Code
    OYX
    PMA / PMN Number
    K190076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WAS NO PATIENT HARM, AND NO CHANGES TO THERAPY WERE MADE DUE TO THIS DISCREPANCY, AS THE CLINICIAN ORDERED A REPEAT TEST SINCE THE INITIAL RESULT WAS NOT IN LINE WITH OTHER CLINICAL SYMPTOMS/EXAMINATION. THE CUSTOMER DOES NOT EXCLUDE THE POSSIBILITY OF OPERATOR'S ERROR, ALTHOUGH AS STATED BY HIM THIS IS HIGHLY UNLIKELY. FACTORS THAT COULD HAVE LED TO THE FALSE NEGATIVE RESULT INCLUDE OMITTING ETOH (ETHANOL) OR ADDING THE SAMPLE/WASH REAGENT INTO THE WRONG OPENING. THEY RAN ADDITIONAL TESTING WITH INTENTIONAL MISTAKES ATTEMPTING TO REPRODUCE A POTENTIAL OPERATOR MISTAKE: WHEN THEY SWAPPED THE CHAMBERS WHEN ADDING THE SAMPLE AND WASH BUFFER, THIS LED TO A FALSE NEGATIVE. LOT 41901/1001445060 MET ALL RELEASE QC SPECIFICATIONS. NO OTHER DISCREPANCIES HAVE BEEN REPORTED TO DATE FOR (B)(4) CARTRIDGES SHIPPED, THEREFORE, SYSTEMIC LOT MALFUNCTION IS UNLIKELY. IN-HOUSE TESTING RESULTS SHOWED NO SIGNIFICANT DIFFERENCES BETWEEN THE ORIGINAL RELEASE DATA AND THE RETAIN TESTING OF LOT 41901. CEPHEID WAS NOT ABLE TO REPRODUCE ANY SIGNIFICANT ANOMALY THAT COULD HAVE LED TO THE FALSE NEGATIVE RESULT. NO MALFUNCTION COULD BE CONFIRMED. INTERNAL REVIEW OF THE TEST CURVE INDICATED IT COULD BE AN ISOLATED ANOMALY. HOWEVER ALTHOUGH ALL TESTS PERFORMED, A ONE-TIME CARTRIDGE MALFUNCTION CANNOT BE EXCLUDED. ALL ANNEX CODES HAVE BEEN UPDATED TO REFLECT THE COMPLETION OF THE INVESTIGATION. H1 AND B1 HAVE BEEN UPDATED ACCORDINGLY FOLLOWING THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT WHEN RUNNING XPERT BCR-ABL ULTRA WITH A STANDARD 4 ML WHOLE BLOOD PROTOCOL. WHEN THE TEST WAS REPEATED FROM THE FROZEN LYSATE, THE RESULT WAS 0.22%. ANOTHER BLOOD SPECIMEN WAS OBTAINED FROM THE PATIENT. TEST RESULT FROM THIS FRESHLY COLLECTED BLOOD SPECIMEN WAS 0.77%. THERE WAS NO PATIENT HARM, AND NO CHANGES TO THERAPY WERE MADE DUE TO THIS DISCREPANCY, AS THE CLINICIAN ORDERED A REPEAT TEST SINCE THE INITIAL RESULT WAS NOT IN LINE WITH OTHER CLINICAL SYMPTOMS/EXAMINATION. THE CUSTOMER DOES NOT EXCLUDE THE POSSIBILITY OF OPERATOR'S ERROR, ALTHOUGH AS STATED BY THE CUSTOMER THIS IS HIGHLY UNLIKELY. FACTORS THAT COULD HAVE LED TO THE FALSE NEGATIVE RESULT INCLUDE OMITTING ETOH (ETHANOL) ADDITION OR ADDING THE SAMPLE/WASH REAGENT INTO THE WRONG OPENING. ADDITIONAL SAMPLES ARE BEING RUN BY THE CUSTOMER TO EXCLUDE IT. LOT 41901 MET ALL RELEASE QC SPECIFICATIONS. NO OTHER DISCREPANCIES HAVE BEEN REPORTED TO DATE FOR 11260 CARTRIDGES SHIPPED, THEREFORE, SYSTEMIC LOT MALFUNCTION IS UNLIKELY. HOWEVER, ISOLATED CARTRIDGE MALFUNCTION CANNOT BE EXCLUDED. THE ROOT CAUSE IS STILL INCONCLUSIVE. THEREFORE, THE INVESTIGATION IS ONGOING, WITH THE R&D TEAM TO WHOM THE CURVES WERE SENT FOR ANALYSIS. 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 XPERT BCR-ABL ULTRA TEST AND THE UNAVAILABILITY OF THAT PRODUCT LOT TO BE RETURNED TO CEPHEID.

    Description of Event or Problem · 0

    ON (B)(6)2025 AT 13:30, PATIENT WHOLE BLOOD SAMPLE WAS COLLECTED IN 2 EDTA (ETHYLENEDIAMINETETRAACETIC ACID) TUBES, 4 ML EACH. 2 ML OF EACH WERE TAKEN AND USED FOR TESTING ON BCR-ABL ULTRA (BREAKPOINT CLUSTER REGION-ABELSON) CARTRIDGE LOT 41901. THE TEST RESULT REPORTED: NEGATIVE [SUFFICIENT ABL TRANSCRIPT]. UPON CLINICIAN'S REVIEW, CLINICIAN REQUESTED ANOTHER TEST TO BE DONE AS THE RESULT DID NOT CORRELATE WITH PATIENT'S PRIOR DIAGNOSIS AND CURRENT TREATMENT. ON (B)(6)2025, PATIENT WHOLE BLOOD SAMPLE WAS COLLECTED AGAIN IN 2 EDTA TUBES, 4 ML EACH. 2 ML OF EACH WERE TAKEN AND USED FOR TESTING ON 1 BCR-ABL ULTRA CARTRIDGE FROM THE SAME LOT 41901. TEST RESULT REPORTED: POSITIVE [0.22% (INTERNATIONAL SCALE - IS) AND MR2.66 (MOLECULAR RESPONSE)]. ON (B)(6)2025, CUSTOMER CONTACTED TECHNICAL SUPPORT TO REPORT THIS QUESTIONABLE NEGATIVE RESULT ON XPERT BCR-ABL ULTRA LOT 41901. CUSTOMER WOULD LIKE TO KNOW THE POSSIBLE REASONS BEHIND THE DISCREPANCY. THE PATIENT IS CURRENTLY FOLLOWING A TREATMENT FOR CHRONIC MYELOID LEUKAEMIA. THERE WAS NO HARM TO THE PATIENT. THERE WERE NO CHANGES TO THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031345 XPERT BCR-ABL ULTRA XPERT BCR-ABL ULTRA OYX CEPHEID 1001445060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown