BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ONCLARITY¿ HPV ASSAY REAGENT PACK

    MDR report key: 18393340 · Received December 26, 2023

    Report

    Report Number
    1119779-2023-01435
    Event Type
    Malfunction
    Date Received
    December 26, 2023
    Date of Event
    December 4, 2023
    Report Date
    February 9, 2024
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    UDI-DI
    00382904439828
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD INTEGRATED DIAGNOSTIC SYSTEMS INITIATED AN INVESTIGATION INTO FALSE NEGATIVE PATIENT RESULTS ON THE BD COR SYSTEM (CATALOG # 443982, BATCH # 3180726). BD INVESTIGATION ENCOMPASSED REVIEW OF BATCH HISTORY RECORD, REVIEW OF INITIAL QUALITY CONTROL RELEASE DATA, REVIEW OF RETURNED RAW FILES FROM CUSTOMER AND COMPLAINT TRENDING REVIEW. EVALUATION OF THE BATCH HISTORY RECORDS, AND RELEASE DATA REVEALED TRENDS DURING TIME ZERO QUALITY CONTROL TESTING THAT COULD POTENTIALLY CONTRIBUTE TO FALSE NEGATIVE PATIENT RESULTS. ADDITIONALLY, EVALUATION OF RETURNED RAW FILES DID REVEAL FALSE NEGATIVE PATIENT RESULTS, THUS CONFIRMING THE CUSTOMERS REPORT. HOWEVER, IT IS IMPORTANT TO NOTE THAT THE OCCURRENCE RATE OF THE FALSE NEGATIVE PATIENT RESULT IS BELOW THE ACCEPTABLE RATE PRESENTED IN THE PACKAGE INSERT. THERE ARE NO CURRENT TRENDS ASSOCIATED WITH FALSE NEGATIVE PATIENT RESULTS ON THE BD COR SYSTEM. THERE IS AN ESCALATED INVESTIGATION INTO WHAT COULD CAUSE THE TRENDS DURING TIME ZERO TESTING; HOWEVER, NO CORRECTIVE ACTIONS HAVE BEEN TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD ONCLARITY¿ HPV ASSAY REAGENT PACK, A PATIENT SPECIMEN GAVE A FALSE NEGATIVE HPV RESULT. SAMPLE WAS RETESTED WITH ALLPLEX AND GAVE A POSITIVE RESULT. SAMPLE WAS REPORTED AS HPV POSITIVE, SO THERE WAS NO PATIENT IMPACT.

    Description of Event or Problem · 0

    1 OF 2. IT WAS REPORTED THAT WHILE USING THE BD ONCLARITY¿ HPV ASSAY REAGENT PACK, A PATIENT SPECIMEN GAVE A FALSE NEGATIVE HPV RESULT. SAMPLE WAS RETESTED WITH ALLPLEX AND GAVE A POSITIVE RESULT. SAMPLE WAS REPORTED AS HPV POSITIVE, SO THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263123 BD ONCLARITY¿ HPV ASSAY REAGENT PACK HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD MAQ BECTON, DICKINSON & CO. (SPARKS) 3180726 00382904439828

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown