BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR

    MDR report key: 23707789 · Received December 3, 2025

    Report

    Report Number
    1119779-2025-05478
    Event Type
    Malfunction
    Date Received
    December 3, 2025
    Date of Event
    October 31, 2025
    Report Date
    April 6, 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

    INVESTIGATION SUMMARY: THE COMPLAINT INVESTIGATION FOR DISCREPANT RESULT WHEN USING THE BD ONCLARITY¿ HPV ASSAY ON BD COR¿ SYSTEM (REF (B)(4)) FROM KIT LOT 5162898 WAS PERFORMED BY THE REVIEW OF MANUFACTURING RECORDS, RETAIN MATERIAL TESTING, REVIEW OF CUSTOMER¿S DATA AND BY THE COMPLAINT¿S HISTORY REVIEW. THE REVIEW OF QUALITY CONTROL RECORDS OF HPV ASSAY KIT LOT 5162898 REVEALED NO ANOMALIES THAT COULD EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. THE RETAIN MATERIAL OF HPV ASSAY KIT FROM LOT 5162898 WAS TESTED AND THE RESULTS WERE AS EXPECTED. THE CUSTOMER COMPLAINED OF DISCREPANT RESULTS DUE TO THE P2 TARGET, WHICH WAS NEGATIVE ON THE INITIAL TEST AND POSITIVE ON THE RETEST, FOR ONE PATIENT SAMPLE. TWO RUN FILES (HTCRG0038_HPV20251030_134610 AND HTCRG0038_HPV20251031_145256) WERE RECEIVED FOR THE INVESTIGATION AND ANALYZED. THE DISCREPANT RESULTS WERE TESTED ON (B)(6) 2025 (INITIAL) AND (B)(6) 2025 (REPEAT). THE P2 TARGET WAS NEGATIVE ON THE INITIAL TEST BECAUSE NO CYCLE THRESHOLD WAS OBTAINED, THUS CONSIDERED NEGATIVE BY THE SOFTWARE. THE RETEST SHOWS A POSITIVE RESULT FOR THE P2 TARGET (CT 32.7). MANUAL PCR CURVE ADJUDICATION REVEALED LATE AND LOW, BUT TRUE POSITIVE P2 AMPLIFICATION CURVES IN BOTH THE INITIAL TEST AND THE RETEST, SUGGESTING VARIABLE RESULTS DUE TO SAMPLE HOMOGENEITY AND/OR TARGET CONCENTRATION NEAR THE ASSAY LIMIT OF DETECTION. ACCORDING TO THE PACKAGE INSERT, DETECTION OF HIGH-RISK HPV IS DEPENDENT ON THE NUMBER OF COPIES PRESENT IN THE SPECIMEN AND MAY BE AFFECTED BY MULTIPLES FACTORS. NEVERTHELESS, MANUAL CURVE ADJUDICATION HAS LIMITATIONS; VISUAL EXAMINATION OF PCR CURVES FOR LOW SIGNAL IS A CONSERVATIVE ASSESSMENT OF THE DATA. THE BD ONCLARITY ASSAY WAS DESIGNED WITH CLINICAL CUT-OFF THRESHOLDS, NOT ANALYTICAL CUT-OFF THRESHOLDS, MEANING THAT FOR LOW POSITIVE PATIENT SAMPLES, DETECTION IS NOT 100% AS THOSE PATIENT SAMPLES MAY NOT HAVE A SIGNIFICANT AMOUNT OF THE VIRUS TO INDICATE PRE-CANCER OR CANCER. THE GOAL OF HPV SCREENING IS NOT TO DETECT THE HPV VIRUS BUT RATHER TO DETERMINE THE LEVEL OF INFECTION THAT IS ASSOCIATED WITH THE DEVELOPMENT OF CIN2+ DISEASE AS VERIFIED BY HISTOLOGY. BASED ON THE DATA AND INFORMATION PROVIDED, SAMPLE AT ASSAY LIMIT OF DETECTION OR SAMPLE HOMOGENEITY ISSUES ARE THE MOST LIKELY CAUSES TO EXPLAIN THE CUSTOMER¿S DISCREPANT RESULTS. NO REAGENTS ISSUE IS SUSPECTED. THERE IS NO INDICATION OF A REAGENT ISSUE BASED ON THE ANALYSIS OF THE COMPLAINTS RECEIVED FOR DISCREPANT RESULTS ON THE HPV ASSAY KIT LOT 5162898. THE ROOT CAUSE WAS NOT IDENTIFIED. BD CANNOT CONFIRM THE COMPLAINT BASED ON THE INVESTIGATION THAT WAS PERFORMED. BD DID NOT INITIATE A CORRECTIVE AND PREVENTIVE ACTION SINCE NO NEW HAZARD WAS IDENTIFIED.

    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

    IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR, A DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS HPV P2 NEGATIVE, AND REPEAT TEST WAS HPV P2 POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR, A DISCREPANT PATIENT RESULT WAS OBTAINED. INITIAL TEST WAS HPV P2 NEGATIVE, AND REPEAT TEST WAS HPV P2 POSITIVE. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28193 BD ONCLARITY¿ HPV ASSAY REAGENT PACK FOR BD COR HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD MAQ BECTON, DICKINSON & CO. (SPARKS) 5162898 00382904439828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown