BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROL SET FOR THE BD ONCLARITY HPV ASSAY

    MDR report key: 12132212 · Received July 7, 2021

    Report

    Report Number
    1119779-2021-01146
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 14, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING ONE (1) HPV POSITIVE CONTROL WITH MISSING 2D BARCODE & BATCH/EXPIRATION INFORMATION. QUALITY INVESTIGATION REQUIRED REVIEW OF THE BATCH HISTORY RECORDS, INSPECTION OF RETENTION MATERIALS AND COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. VISUAL INSPECTION OF RETENTION MATERIALS REVEALS ALL LABELING IS SATISFACTORY. QUALITY WAS UNABLE TO CONFIRM THE CUSTOMERS REPORTED FAILURE MODE. THERE ARE NO CURRENT COMPLAINT TRENDS AGAINST CONTROL TUBES WITH MISSING 2D BARCODE & BATCH/EXPIRATION INFORMATION. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH MISSING 2D BARCODE & BATCH INFORMATION ON CONTROL TUBES. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING CONTROL SET FOR THE BD ONCLARITY¿ HPV ASSAY A MISSING LABEL WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POSITIVE CONTROL WITHOUT QR CODE A SINGLE POSITIVE CONTROL TO USE ON THE BD VIPERLT HAD NO QR CODE LABEL"

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE CONTROL SET FOR THE BD ONCLARITY¿ (B)(6) ASSAY CATALOG NUMBER 444088 WHICH HAS 510K NUMBER P160037.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING CONTROL SET FOR THE BD ONCLARITY¿ (B)(6) ASSAY A MISSING LABEL WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "POSITIVE CONTROL WITHOUT QR CODE. A SINGLE POSITIVE CONTROL TO USE ON THE BD VIPERLT HAD NO QR CODE LABEL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023463 CONTROL SET FOR THE BD ONCLARITY HPV ASSAY HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD MAQ BECTON, DICKINSON & CO. (SPARKS) 0321897

    Patients

    Seq Age Sex Outcome Treatment
    1