BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XPERT BCR-ABL ULTRA

    MDR report key: 22171358 · Received June 9, 2025

    Report

    Report Number
    3004530258-2025-00020
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Date of Event
    April 22, 2025
    Report Date
    July 9, 2025
    Manufacturer
    CEPHEID
    Product Code
    OYX
    PMA / PMN Number
    K190076
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICALLY ADVISORY BOARD CONCLUDED THE LIKELY ROOT CAUSE FOR THE UNDER QUANTITATION RESULT ASSOCIATED WITH XPERT BCR-ABL ULTRA LOT 40801 AND BATCH ID 1001420864 TO BE INCONCLUSIVE. HOWEVER, THE SPECIMEN STORAGE WAS NOT DONE CORRECTLY BY THE CUSTOMER AND DID NOT MEET THE LABELED REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED UNEXPECTED TEST RESULT FROM ONE PATIENT. THIS WAS A CONFIRMED BCR: ABL1 P210 CML PATIENT ON TKI TREATMENT DURING MONITORING. TEST WAS PERFORMED ON (B)(6) 2025 AND THE TEST RESULT WAS POSITIVE [0.0048% IS MR 4.32]. BLOOD SPECIMEN WAS NOT REFRIGERATED AS PER IFU, BUT STORED AT ROOM TEMPERATURE (RT) FOR ABOUT HALF A DAY WHICH CLASSIFIES THE USE AS OFF-LABEL. THE REPEAT TEST WAS PERFORMED FROM THE FIRST LYSATE AS A RESULT OF 25FAR005 CUSTOMER LETTER STATING THAT XPERT BCR-ABL ULTRA LOT: 40801 WAS EXPOSED TO WRONG STORAGE CONDITIONS. AS CONFIRMED BY CEPHEID, THIS SHIPMENT WAS NOT EXPOSED TO WRONG STORAGE CONDITIONS AS IT WAS SHIPPED FROM A DIFFERENT WAREHOUSE. THE REPEAT TEST WAS RUN FROM CORRECTLY STORED FIRST LYSATE THAT WAS MAINTAINED AT -20C FOR 4 WEEKS. REPEAT RESULT WAS POSITIVE [0.031% IS MR3.51] AND WAS TESTED WITH A DIFFERENT LOT OF REAGENTS (29801/1001406734). BOTH RESULTS WERE REPORTED TO THE TREATING PHYSICIAN. ALTHOUGH BOTH RESULTS ARE <0.1% IS, THE FIRST RESULT MIGHT HAVE GIVEN FALSE LEVEL OF SAFETY AS THE PATIENT WENT FROM MMR TO DEEP MOLECULAR RESPONSE DMR (<0.01% IS) AND THEN RETURNED TO MMR. NO PATIENT HARM WAS REPORTED. NO REPEAT TESTING WAS DONE WITH THE SAME LOT OF REAGENTS. NO FOLLOWING MONITORING SAMPLE RESULTS ARE AVAILABLE AS OF NOW. POTENTIAL ROOT CAUSE IS INCONCLUSIVE AT THIS STAGE BUT COULD BE RELATED TO SAMPLE STORAGE AT ROOM TEMPERATURE, SAMPLE PROCESSING (AS REPEAT TEST FROM THE LYSATE RESULTED IN HIGHER QUANTIFICATION), OR COULD BE RELATED TO AN ISOLATED CARTRIDGE MISQUANTIFICATION. THE INVESTIGATION IS STILL ONGOING. CEPHEID IS REACHING OUT TO THE CUSTOMER TO OBTAIN FURTHER ANSWERS. 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, CUSTOMER CONTACTED CEPHEID TO REPORT A QUESTIONABLE MISQUANTITATION RESULT WITH XPERT BCR-ABL ULTRA LOT: 40801/ 1001420864. CONTEXT: THE PATIENT HAS BEEN DIAGNOSED WITH CHRONIC MYELOID LEUKEMIA (CML) AND IS ON TYROSINE KINASE INHIBITORS (TKIS) TREATMENT. CLINICAL ASSESSMENTS WERE PERFORMED TO CONFIRM THE DIAGNOSIS INCLUDING HEMATOLOGICAL BLOOD COUNTS, BONE MARROW FLUORESCENCE-ACTIVATED CELL SORTING (FACS), MORPHOLOGY, KARYOTYPING, AND FLUORESCENCE IN SITU HYBRIDIZATION (FISH). AT DIAGNOSIS, THE WHITE BLOOD CELL (WBC) COUNT WAS 188,000/L. IN THE FOLLOW-UP SAMPLE TESTED WITH LOT: 40801/ 1001420864, THE WBC COUNT WAS 5,900/L. EVENT: ON 22-APR-2025, A 5 ML WHOLE BLOOD SAMPLE WAS COLLECTED IN AN EDTA TUBE. THE SAMPLE WAS LEFT AT ROOM TEMPERATURE AND TESTED THE SAME DAY USING 4 ML ON THE XPERT BCR-ABL ULTRA ASSAY, LOT: 40801/ 1001420864, ADF VERSION 1. THE RESULT WAS POSITIVE WITH AN INTERNATIONAL SCALE (IS) VALUE OF 0.0048% AND A MOLECULAR RESPONSE (MR) OF 4.32. THIS RESULT WAS REPORTED TO THE PHYSICIAN. THE LYSATE FROM THIS SAMPLE WAS STORED AT -20°C FOR FOUR WEEKS. ON (B)(6) 2025, A RETEST WAS PERFORMED USING THE STORED LYSATE ON THE XPERT BCR-ABL ULTRA ASSAY, LOT: 29801/1001406734, ADF VERSION 1. THE RESULT WAS ALSO POSITIVE, WITH AN IS OF 0.031% AND AN MR OF 3.51. THIS RESULT WAS ALSO REPORTED TO THE PHYSICIAN. THERE WAS A 6.45-FOLD DIFFERENCE BETWEEN THE TWO RESULTS. ALTHOUGH THERE WAS NO CHANGE IN THERAPY, THE DISCREPANCY GAVE A FALSE SENSE OF SAFETY. THE PATIENT APPEARED TO MOVE FROM MAJOR MOLECULAR RESPONSE (MMR) TO MR4 DUE TO THE LOWER BCR-ABL LEVEL BUT IS NOW CONSIDERED TO BE IN MMR AGAIN. THERE WAS NO HARM TO THE PATIENT, AND NO ADDITIONAL MONITORING SAMPLES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1631503 XPERT BCR-ABL ULTRA XPERT BCR-ABL ULTRA OYX CEPHEID 1001420864

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown