BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTROL SET FOR THE BD ONCLARITY HPV ASSAY

    MDR report key: 12063026 · Received June 24, 2021

    Report

    Report Number
    1119779-2021-01053
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    April 8, 2021
    Report Date
    June 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    MAQ
    PMA / PMN Number
    P160037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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. INVESTIGATION SUMMARY: BD MOLECULAR QUALITY INITIATED INVESTIGATION ON THE CUSTOMER REPORT REGARDING SEVERAL INVALID (B)(6) CONTROL RESULTS ON THE BD COR 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. THERE ARE NO CURRENT COMPLAINT TRENDS AGAINST INVALID (B)(6) CONTROL RESULTS. WITH RESPECT TO INVALID (B)(6) CONTROL RESULTS, RIGOROUS DAILY CLEANING, ROUTINE MONITORING AND IDENTIFICATION OF HBB SOURCES, AND CAUTIOUS HANDLING OF REAGENT (ALONG WITH REQUIRED CHANGES OF PPE [GLOVES]) SHOULD BE EMPLOYED TO SAFEGUARD AGAINST FUTURE ONSITE (HBB) CONTAMINATION OF THE (B)(6) CONTROL. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH INVALID (B)(6) CONTROL RESULTS ON THE BD COR 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 · 0

    IT WAS REPORTED THAT WHILE USING 3 CONTROL SETS FOR THE BD ONCLARITY¿ (B)(6) ASSAY CONTAMINATION 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: " WHEN WE GOT CONTAMINATION FOR THE FIRST TIME 8/4. THE 2ND TIME WE GOT CONTAMINATION WAS 3/5"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    953086 CONTROL SET FOR THE BD ONCLARITY HPV ASSAY HUMAN PAPILLOMAVIRUS HIGH-RISK STRAIN NUCLEIC ACID IVD MAQ BECTON, DICKINSON & CO. (SPARKS) 0055436

    Patients

    Seq Age Sex Outcome Treatment
    1