BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR

    MDR report key: 23280895 · Received October 15, 2025

    Report

    Report Number
    1119779-2025-05094
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    September 16, 2025
    Report Date
    January 30, 2026
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    UDI-DI
    00382904439828
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: IMDRF ANNEX A GRID: A090803 FALSE NEGATIVE RESULT (1225).

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD INITIATED AN INVESTIGATION REGARDING THE REDUCED FLUORESCENCE OBSERVED WITH PCR PLATE LOT 5059186 AND THE OCCURRENCE OF FALSE NEGATIVE RESULTS. THE CUSTOMER SELECTED A SUBSET OF SPECIMENS NEAR THE THRESHOLD OF THE ASSAY AND RETESTED THEM USING A PREVIOUS REAGENT LOT. THE INVESTIGATION REQUIRED REVIEW OF THE CUSTOMER COMPLAINT HISTORY, REVIEW OF THE BHR RECORDS, AND REVIEW OF THE CUSTOMER PROVIDED RUN FILES. MOREOVER, BD DISPATCHED A FIELD SERVICE ENGINEER TO OBTAIN RUN FILES FOR THE YEARS 2024 AND 2025 ON BOTH BD COR SYSTEMS INSTALLED AT THE CUSTOMER¿S SITE. THE CUSTOMER NOTED FOURTEEN (14) FALSE NEGATIVE RESULTS ASSOCIATED WITH THE PCR PLATE LOT CHANGE. TO VERIFY THIS CLAIM, THE CUSTOMERS BD COR DATABASE SHOWED 197 INDIVIDUAL SPECIMENS THAT HAD PAIRED RESULTS FOR BOTH THE 5059186 AND THE 5052509 PCR PLATE LOTS. OF THE 197 SPECIMENS, 56 DEMONSTRATED HPV AMPLIFICATION OF AT-LEAST ONE GENOTYPE WHETHER IT WAS DEEMED POSITIVE OR NEGATIVE BASED UPON THE CLINICAL THRESHOLD. SOME OF THESE SPECIMENS WERE POSITIVE FOR MULTIPLE GENOTYPES. A DEMING REGRESSION WAS PERFORMED COMPARING THE CT.SCORE METRICS. A DEMING REGRESSION IS A STATISTICAL TEST THAT DETERMINES IF THE RESULT OF THE TWO DIFFERENT FACTORS ARE SIGNIFICANTLY DIFFERENT WITHIN A DEFINED MARGIN OF ERROR. UNDER IDEAL CIRCUMSTANCES, THE TWO VARIABLES WOULD HAVE A SLOPE OF 1 INDICATING EQUIVALENT PERFORMANCE. THE RESULT OF THE ANALYSIS INDICATED A SLOPE OF 1.00850 (95% CI = 0.90087 - 1.11614). THE RESULTING SLOPE OVERLAPS WITH 1 CONFIRMING THAT THE TWO REAGENT LOTS ARE PERFORMING SIMILARLY. THE MARGIN OF ERROR USED WAS BASED UPON THE REPRODUCIBILITY STUDY IN THE PACKAGE INSERT THAT LISTS THE STANDARD DEVIATION FOR POOLED POSITIVE SUREPATH SPECIMENS RANGING FROM 0.64 TO 2.49 WITH AN AVERAGE OF 1.59. THEREFORE, WE CAN CONCLUDE BASED ON THIS DATA SET THAT THE PERFORMANCE OF THE TWO PLATE LOTS IS NOT SIGNIFICANTLY DIFFERENT IN TERMS OF CLINICAL PERFORMANCE. BY INTENTIONALLY RETESTING SPECIMENS AROUND THE CUTOFF, THE CUSTOMER IS ENRICHING THE FALSE NEGATIVE AND/OR FALSE POSITIVE RATE, AND THIS METHODOLOGY IS NOT WITHIN THE INTENDED USE OF THE ASSAY. BASED ON THE DATA, THE CUSTOMER VIEWS THE HPV ASSAY AS A MOLECULAR/INFECTIOUS DISEASE ASSAY. THE HPV ASSAY WAS VALIDATED AS A MEASUREMENT OF RISK FOR FUTURE DISEASE PROGRESSION RELATING TO CERVICAL CANCER.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    REPORT 4 OF 14: IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR, A FALSE NEGATIVE PATIENT RESULT WITH UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS REPEATED AND WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 4 OF 14: IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR, A FALSE NEGATIVE PATIENT RESULT WITH UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS REPEATED AND WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 4 OF 14: IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR, A FALSE NEGATIVE PATIENT RESULT WITH UNUSUAL PCR CURVE WAS OBTAINED. TEST WAS REPEATED AND WAS POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190054 BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD MAQ BECTON, DICKINSON & CO. (SPARKS) 5076477 00382904439828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown