BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ONCLARITY HPV ASSAY REAGENT PACK

    MDR report key: 20207268 · Received September 12, 2024

    Report

    Report Number
    1119779-2024-00670
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    June 28, 2024
    Report Date
    September 13, 2024
    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: BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED AN INVESTIGATION INTO DISCREPANT PATIENT RESULTS ON THE HPV ASSAY FOR THE BD COR SYSTEM (CATALOG # 443982, BATCH # 4002724 & 4040017). BD INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS, REVIEW OF CUSTOMER RETURNED RAW FILES, FUNCTIONAL ANALYSIS OF THE CUSTOMERS REPORTED REAGENT BATCH AND COMPLAINT HISTORY REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. BD ACKNOWLEDGES THE PATIENT DISCREPANT RESULTS THROUGH REVIEW OF CUSTOMER RETURNED RAW FILES. HOWEVER, FUNCTIONAL ANALYSIS WAS PERFORMED ON THE CUSTOMER REPORTED REAGENT BATCH AND MET ACCEPTANCE CRITERIA WITH 100% POSITIVITY. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMERS REPORT. THERE ARE NO CURRENT COMPLAINT TRENDS ASSOCIATED WITH DISCREPANT PATIENT RESULTS ON THE HPV ASSAY. BD QUALITY WILL CONTINUE TO MONITOR FOR TRENDS ASSOCIATED WITH DISCREPANT PATIENT RESULTS ON THE HPV ASSAY.

    Additional Manufacturer Narrative · 0

    E.1: INITIAL REPORTER FACILITY NAME: (B)(6). 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 3 OF 3: IT WAS REPORTED THAT DURING USE OF THE BD ONCLARITY HPV ASSAY REAGENT PACK, A FALSE NEGATIVE PATIENT RESULT WAS OBTAINED. THE SAMPLE WAS RETESTED ON COR AND ALLPLEX AND WAS POSITIVE FOR VARIOUS GENOTYPES AND SENT TO CYTOLOGY. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    REPORT 3 OF 3: IT WAS REPORTED THAT DURING USE OF THE BD ONCLARITY HPV ASSAY REAGENT PACK, A FALSE NEGATIVE PATIENT RESULT WAS OBTAINED. THE SAMPLE WAS RETESTED ON COR AND ALLPLEX AND WAS POSITIVE FOR VARIOUS GENOTYPES AND SENT TO CYTOLOGY. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516740 BD ONCLARITY HPV ASSAY REAGENT PACK HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD MAQ BECTON, DICKINSON & CO. (SPARKS) 4040017 00382904439828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown