BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT BD ONCLARITY HPV ASSAY RGT PACK E

    MDR report key: 12018816 · Received June 17, 2021

    Report

    Report Number
    1119779-2021-01002
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 7, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING ONE (1) RUN WITH SEVERAL SPECIMENS WITH HIGH(B)(6) (GREATER THAN A ZERO [0] CT) VALUES FOR (B)(6) 16 ON THE BD VIPER LT SYSTEM. QUALITY INVESTIGATION REQUIRED REVIEWED OF THE BATCH HISTORY RECORDS AND FUNCTIONAL ANALYSIS OF RETENTION MATERIALS FROM THE CUSTOMER REPORTED REAGENT BATCHES AS WELL AS COMPLAINT TRENDING REVIEW. THE BATCH HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE NOTED. FUNCTIONAL ANALYSIS OF RETENTION MATERIALS MET ACCEPTANCE CRITERIA. THERE ARE NO COMPLAINT TRENDS AGAINST SEVERAL SPECIMENS WITH HIGH NEGATIVE (GREATER THAN A ZERO [0] CT) VALUES ON THE BD VIPER LT SYSTEM. IT IS IMPORTANT TO NOTE IF THE HBB (INTERNAL CONTROL) RESULT PASSES FOR A GIVEN SPECIMEN AND THE (B)(6) CONTROL FOR A GIVEN RUN PASSES, THE RESULT SHOULD BE DEEMED VALID (A CORRECT (B)(6) RESULT IN THE AFOREMENTIONED CASES). BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH (B)(6) (GREATER THAN A ZERO [0] CT) VALUES ON THE BD VIPER LT SYSTEM. THERE WAS NO CORRECTIVE ACTION TAKEN AT THIS TIME. IF YOU HAVE ANY ADDITIONAL QUESTIONS OR CONCERNS, PLEASE DO NOT HESITATE TO CONTACT BD TECHNICAL SERVICES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING KIT BD ONCLARITY HPV ASSAY RGT PACK EU 30 (B)(6) RESULTS WERE OBTAINED 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: "TODAY I HAVE REQUEST FROM LAB WITH BD VIPER LT FROM ZAMOSC  RUN WAS DONE YESTERDAY, WITH 30 PATIENT SAMPLES. CT OF QC (B)(6) SHOULD BE -1, IS 38, 5 BUT 14 WOMEN HAVE (B)(6), 16 WITH CT 38,3 OR 38,2. . I HAVE NEVER SEEN THIS KIND OF RESULTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918489 KIT BD ONCLARITY HPV ASSAY RGT PACK E HUMAN PAPILLOMAVIRUS (HPV) HIGH-RISK STRAIN NUCLEIC ACID IVD, CONTROL MAQ BECTON, DICKINSON & CO. (SPARKS) 0364610

    Patients

    Seq Age Sex Outcome Treatment
    1